INTRODUCTION :
Dental caries remains a fundamental concern of today’s practice and continues to be one of the most common disease in the world , despite the significant progress of research and diffused home-practice of oral hygiene .the current concept of the caries forming process is based on the accumulation of numerous episodes of demineralization and remineralization , initiated by acid producing bacteria in the oral micro-environment .(1)
At the early stage of dental caries process , the relationship between pathogenic and protective factor is dynamic and thoroughly reversible(2) .
White spot lesion marks The initial stage of demineralization , which follows carious progression in enamel , which can be reversed . enamel demineralization causes loss of minerals on the outer surface which result in increase in porosity . it is considered if enamel appears rough and opaque or inactive with a smooth and shiny appearance.(3)
Conversely , remineralization occurs when the calcium, phosphate gradient invert and spread towards inside of the lesion . Natural remineralization in the initial phase is stimulated by saliva , which contains calcium ion , phosphate ion , buffer agents , fluoride and other substances . however , when this ideal condition is lacking , topical agents become essential to avoid demineralization(4).
Dental caries can be prevented by enhancing remineralization and increasing resistance of teeth to acid , Many non – invasive therapies can be used such as fluoride for controlling the progression of carious lesion.(2)
Many researches shows that fluoride varnishes can used to prevent demineralization process of an initial carious lesion as it reverse and arrests the lesion. The presence of fluoride ions in the oral cavity causes the fluorapatite to precipitate the calcium and phosphate ion existing into the saliva .the increase in PH will therefore lead to the formation of larger crystals resistant to fluorine containing acids (Fluro hydroxyapatite) , developing a strong surface layer which increase the resistance to demineralization, however products containing calcium, phosphate , phosphate and fluoride in their bio-available forms have claimed to increase remineralization over products containing only fluoride . These include fluoride varnishes with added calcium and phosphate have been introduced recently(5) .
Casein phosphopeptide (CPP) are derived from casein digestion by trypsin enzyme. Amorphous calcium phosphate (ACP) with 5% NaF are added to CPP , which is novel agent for prevention and arresting of dental caries , application of CPP-ACP along with fluoride reduce the degree of demineralization of white spot lesion in clinical study(5)
Xylitol intake leads to favorable results like low incidence of caries and S. mutans level in oral flora due to inefficiency of five carbon sugar xylitol to be fermented by S. mutans . Xylitol incorporated varnishes have shown to be favorable substitute to increase enamel remineralization (6)
And a light cure glass ionomer based resin which is also contain fluorides, calcium and phosphate which help in supplementing the remineralization process and also help in reducing dentinal hypersensitivity(7)
These topical agents show promise in their ability to prevent enamel demineralization , these are the most advanced fluoride varnishes , due to addition of calcium and phosphate ions it prevents enamel demineralization as it supplements the saliva with increased ion which in turn causes remineralization by fluoride(8)
AIM-To evaluate the remineralizing potential of remineralizing agents (MI Varnish , Clinpro XT , embrace varnish ) on white spot lesions of enamel
OBJECTIVE- To compare the efficacy of different remineralizing potential of remeneralizing agents with the help of diagnodent fluorescence pen used in this study on white spot lesions.
REVIEW OF LITRATURE-
SeppaL , et al in (9) (1981) sodium fluoride has been an potential remineralizing agent used in early carious lesion . they showed that semi- annual application of fluoride varnishes is a caries preventive measure worth consideration even when fluoride intake from other source is optimal .
Jn ten cate (10)–(1990)he stated that fluoride is effective in sub-ppm concentration as it promotes mineral deposition and hamper mineral dissolution .the concomitment precipitation of fluoride rich mineral phase which inhibits further mineral dissolution , causes reserve of enamel demineralization , enhancement of enamel remineralization .
B.R. Schmehron , et al in (11) (2011) evaluate the success of ACP varnish as remineraling agent as it deliver significant more fluoride to both intact and demineralized enamel.
TulogluN ,et al in (12) (2016) conducted a study to investigate the effects of three fluoride varnishes with added casein phosphopeptide -amorphous calcium phosphate treatment on acid resistance of primary teeth enamel , within the limitation of this study , fluoride varnish containing CPP-ACP is more effective increasing the acid resistance of primary enamel than other fluoride varnishes.
MarijaBorisovaite, et al in (13)(2016) stated that white spot lesion can be remineralized by the use of toothpaste containing fluoride , and also observed that fluoride varnish and casein supplements were efficacious in early treatment and cessation of white spot lesion .
Mahdi Shahmoradi , et al in (14) (2017)conducted a study and evaluated that fluoride varnish with added CPP is efficient enough to protect enamel structure.he find out that the depth of lesion with no fluoride varnish was 86+_7.19 whereas depth of lesion after treated with varnish is 67+_7.03
Bayraks ,et al in (15)(2017) Conducted a study to find out that fluoride varnish with added CPP-ACP showed effective result for prevention of enamel erosion .
Kurt wolffGmbH, et al in (16) (2018) evaluated that casein phosphate due to their similar structure as enamel is very useful for daily oral health care as it resulted in remineralization of initial caries and restore small defects .
S Hekmatfar , et al in (17) (2018) conducted a study to evaluate the comparison of calcium uptake by intact enamel after using two types of CPP-ACP and stated that CPP-ACP with sodium floride have better ability to uptake calcium.
Vincenzo Tosco, et al in (1) (2020) conducted a study to evaluate effect of different remineralization agents on the enamel patten after exposure to an acid solution , and come to conclusion that CPP-ACP with sodium monoflurophosphate could represents the most effective protocol for re -establishing the intact enamel structure, given acid environment.
METHDOLOGY .
A)STUDY DESIGN- The present study is a randomised controlled clinical trial which will be conducted in the Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, King George’s Medical University Lucknow.
The rights of the patients will be protected and the parents/guardian accompanying the patients will be explained in detail about the purpose, methodology involved and the related risks and benefits, in a language well understood by them and written informed consent will be obtained. The study will be started only after the ethical approval by the Institutional Ethical Committee of King George’s Medical University, Lucknow.
MATERIALS-
· Saline
· Dry cotton gauge
· MI varnish(CPP+ACP, 5% NaF)
· Clinpro XT varnish( Resin modified glass ionomer)
· Embrace Varnish (CXP, with NaF)
B) STUDY PARTICIPANTS
Patients within age group 5-13 years , irrespective of gender and socioeconomic status will be enrolled in study.
INCLUSION CRITERIA
· The children should be in the range of 5-13 years.
· Teeth should be fully erupted (permanent incisors and canine ) with active white spot lesion with complete and intermittent tooth surface
EXCLUSION CRITERIA
· Patients who used medicaments
· Patient with orthodontic devices
· Patient who are allergic to milk
· Patients who have cavitated carious lesion or enamel defects
NUMBER OF GROUPS TO BE STUDIED, IDENTIFICATION OF GROUPS WITH DEFINATION
Informed consent will be obtained from the parents. All participants will be screened by taking a detailed history and performing a thorough clinical examination. The final selected teeth with active white spot lesion in permanent incisors and canine from the screened participants, that meet all the inclusion and exclusion criteria will be divided randomly into three groups depending upon the type of varnish used
i. GROUP 1-embrace varnish ( study group)
ii. Group 2 – clinpro XT ( study group )
iii. Group 3 – MI varnish ( control group)
C) SAMPLING
SAMPLING POPULATION
The sampling population will consist of the patients within 5-13 years of age, having teeth with active white spot lesion in permanent incisors and canine , which will be selected from the outpatient unit of the Paediatric and Preventive Dentistry Department, Faculty of Dental Sciences, King George’s Medical University, Lucknow.
SAMPLE SIZE
According to statistical calculation approximately 15 teeth shall be included in each group.
SAMPLE SIZE CALCULATION
At 90 % Power
Sample size is calculated on the basis of IQR (interquartile range) of lesion intensity in one of the study groups using the formula :
Where s = 4, The IQR of CPP-ACP + fluoride group
d = 0.3 times median lesion intensity (=19), the minimum mean difference consider to be clinically significant
(Ref.Mendes et. al.)
type I error α = 5% corresponding to 95% confidence level
type II error β = 10% for detecting results with 90% power of study
Data loss = 10%
So the required sample size
n = 15 each group
Randmisation- The patients enrolled for the study will be randomly allocated in one of the three groups by block randomization method.
D) STUDY PROCEDURE– All selected permanent teeth shall be randomly divided into three groups depending upon the type of varnish used . after clinical examination brushing and cleaning of the tooth surface is done with the help of gauze of sterile cotton , the white spot lesion is assessed with the help of Diagnodent pen (lesion having numerical score of 14 or equal to 14 or more than it ) total teeth for each study group. Depending on the type of varnish , the teeth will be treated as follows
Group 1- The embrace varnish is applied in thin and uniform layer on the tooth surface using a microbrush , varnish sets after it comes in, contact with saliva and it should remain undisturbed for 4 hrs on the teeth surface .
Group 2 – the clinpro XT varnishis applied in thin and uniform layer on the tooth surface and light cured for the 20 seconds
Group 3- the MI varnish is also applied in thin and uniform layer and should be undisturbed till 4 hour (patients is instructed not to take any antimicrobial agents during this experimental period )
OUTCOME PARAMETERS
Evaluation of remineralizing efficacy of varnishes at follow up of 1day , 1 month , and 3 months.
FOLLOW – UP TIMELINE
All outcomes shall be observed at baseline , 1 day , 1 month , 3 months post treatment for each patient.
E) DATA COLLECTION METHOD:
The data for each to oth will be recorded on individual data record sheet. The final data will be transferred to master data sheet. The data thus obtained will be subjected to statistical analysis.
F) If the clinical trial, whether the registration with CTRI will be done – Yes
G) STATICAL ANALYSIS
Data will be analysed and expressed in mean (SD) for quantitative variable and proportion/percentages for qualitative data. Categorical variables will be compared by using Chi-square test among the groups. The continuous variables will be compared by using one way analysis of variance (ANOVA) test among the groups. Other appropriate tests will be used for the statistical analysis. ‘p’ value < 0.05 will be considered significant.
REFERENCE
1. Wagle M, D’Antonio F, Reierth E, Basnet P, Trovik TA, Orsini G, et al. Dental caries and preterm birth: a systematic review and meta-analysis. BMJ Open. 2018 Mar;8(3):e018556.
2. Samuel V, Ramakrishnan M, Halawany H, Abraham N, Jacob V, Anil S. Comparative evaluation of the efficacy of tricalcium phosphate, calcium sodium phosphosilicate, and casein phosphopeptide – amorphous calcium phosphate in reducing streptococcus mutans levels in saliva. Niger J Clin Pract. 2017;20(11):1404.
3. Use of Casein Amorphous Calcium Phosphate (CPP-ACP) on White-spot Lesions: Randomised Clinical Trial. Oral Health Prev Dent. 2018 Jan 25;16(1):27–31.
4. Tosco V, Monterubbianesi R, Sparabombe S, Orilisi G, Putignano A. In Vitro Investigation of the Effect of Different Remineralizing Agents on Human Enamel. 4(3):7.
5. Ferreira JMS, Aragão AKR, Rosa ADB, Sampaio FC, de Menezes VA. Therapeutic effect of two fluoride varnishes on white spot lesions: a randomized clinical trial. :6.
6. Bapat SA, Shashikiran N, Gaugawd S, Gaonkar N, Taur S, Hadakar S, et al. In-vitro Comparison of Anti-Microbial Efficacy and Enamel Microhardness after Application of Two Types of Fluoride Varnishes. J Clin Diagn Res [Internet]. 2020 [cited 2020 Dec 16]; Available from: https://jcdr.net/article_fulltext.asp?issn=0973-709x&year=2020&volume=14&issue=4&page=ZC05&issn=0973-709x&id=13627
7. Bhat SS, Hegde KS, Rao HA, Sargod SS, Varma V. Comparative Evaluation of Remineralization Potential of Two Varnishes Containing CPP–ACP and Tricalcium Phosphate: An In Vitro Study. Int J Clin Pediatr Dent. 2019 Jun;12(3):233–6.
8. Hicks J, Garcia-Godoy F, Flaitz C. Biological factors in dental caries: role of remineralization and fluoride in the dynamic process of demineralization and remineralization (part 3). J Clin Pediatr Dent. 2004 Apr 1;28(3):203–14.
9. Seppă L, Hausen H, Tuutti H, Luoma H. Effect of a sodium fluoride varnish on the progress of initial caries lesions. Scand J Dent Res. 1983 Apr;91(2):96-8. doi: 10.1111/j.1600-0722.1983.tb00783.x. PMID: 6574585.
10. Cate JMT. In vitro Studies on the Effects of Fluoride on De- and Remineralization. 1990;69:6.
11. Schemehorn BR, Wood GD, McHale W, Winston AE. Comparison of fluoride uptake into tooth enamel from two fluoride varnishes containing different calcium phosphate sources. J Clin Dent. 2011;22(2):51-4. PMID: 21702326.
12. Tuloglu N, Bayrak S, Tunc ES, Ozer F. Effect of fluoride varnish with added casein phosphopeptide-amorphous calcium phosphate on the acid resistance of the primary enamel. BMC Oral Health. 2016 Sep 26;16(1):103. doi: 10.1186/s12903-016-0299-4. PMID: 27670292; PMCID: PMC5036284.
13. Lopatiene K, Borisovaite M, Lapenaite E. Prevention and Treatment of White Spot Lesions During and After Treatment with Fixed Orthodontic Appliances: a Systematic Literature Review. J Oral Maxillofac Res. 2016 Jun 30;7(2):e1. doi: 10.5037/jomr.2016.7201. PMID: 27489605; PMCID: PMC4970501.
14. Shahmoradi M, Hunter N, Swain M. Efficacy of Fluoride Varnishes with Added Calcium Phosphate in the Protection of the Structural and Mechanical Properties of Enamel. Biomed Res Int. 2017;2017:7834905. doi: 10.1155/2017/7834905. Epub 2017 Dec 7. PMID: 29362716; PMCID: PMC5738627.
15. Bayrak S, Tuloglu N, Bicer H, Sen Tunc E. Effect of Fluoride Varnish Containing CPP-ACP on Preventing Enamel Erosion. Scanning. 2017 Jan 9;2017:1897825. doi: 10.1155/2017/1897825. PMID: 29109803; PMCID: PMC5661827.
16. Meyer F, Amaechi BT, Fabritius HO, Enax J. Overview of Calcium Phosphates used in Biomimetic Oral Care. Open Dent J. 2018 May 31;12:406-423. doi: 10.2174/1874210601812010406. PMID: 29988215; PMCID: PMC5997847.
17. Hekmatfar S, Jafari K, Mohammadpour S. An in-vitro Comparison of Calcium Uptake by Intact Enamel after Using two Types of Casein Phosphopeptide-Amorphous Calcium Phosphate Paste. J Res Dentomaxillofac Sci. 2018; 3 (1) :6-11.
INTRODUCTION :
Dental caries remains a fundamental concern of today’s practice and continues to be one of the most common disease in the world , despite the significant progress of research and diffused home-practice of oral hygiene .the current concept of the caries forming process is based on the accumulation of numerous episodes of demineralization and remineralization , initiated by acid producing bacteria in the oral micro-environment .(1)
At the early stage of dental caries process , the relationship between pathogenic and protective factor is dynamic and thoroughly reversible(2) .
White spot lesion marks The initial stage of demineralization , which follows carious progression in enamel , which can be reversed . enamel demineralization causes loss of minerals on the outer surface which result in increase in porosity . it is considered if enamel appears rough and opaque or inactive with a smooth and shiny appearance.(3)
Conversely , remineralization occurs when the calcium, phosphate gradient invert and spread towards inside of the lesion . Natural remineralization in the initial phase is stimulated by saliva , which contains calcium ion , phosphate ion , buffer agents , fluoride and other substances . however , when this ideal condition is lacking , topical agents become essential to avoid demineralization(4).
Dental caries can be prevented by enhancing remineralization and increasing resistance of teeth to acid , Many non – invasive therapies can be used such as fluoride for controlling the progression of carious lesion.(2)
Many researches shows that fluoride varnishes can used to prevent demineralization process of an initial carious lesion as it reverse and arrests the lesion. The presence of fluoride ions in the oral cavity causes the fluorapatite to precipitate the calcium and phosphate ion existing into the saliva .the increase in PH will therefore lead to the formation of larger crystals resistant to fluorine containing acids (Fluro hydroxyapatite) , developing a strong surface layer which increase the resistance to demineralization, however products containing calcium, phosphate , phosphate and fluoride in their bio-available forms have claimed to increase remineralization over products containing only fluoride . These include fluoride varnishes with added calcium and phosphate have been introduced recently(5) .
Casein phosphopeptide (CPP) are derived from casein digestion by trypsin enzyme. Amorphous calcium phosphate (ACP) with 5% NaF are added to CPP , which is novel agent for prevention and arresting of dental caries , application of CPP-ACP along with fluoride reduce the degree of demineralization of white spot lesion in clinical study(5)
Xylitol intake leads to favorable results like low incidence of caries and S. mutans level in oral flora due to inefficiency of five carbon sugar xylitol to be fermented by S. mutans . Xylitol incorporated varnishes have shown to be favorable substitute to increase enamel remineralization (6)
And a light cure glass ionomer based resin which is also contain fluorides, calcium and phosphate which help in supplementing the remineralization process and also help in reducing dentinal hypersensitivity(7)
These topical agents show promise in their ability to prevent enamel demineralization , these are the most advanced fluoride varnishes , due to addition of calcium and phosphate ions it prevents enamel demineralization as it supplements the saliva with increased ion which in turn causes remineralization by fluoride(8)
AIM-To evaluate the remineralizing potential of remineralizing agents (MI Varnish , Clinpro XT , embrace varnish ) on white spot lesions of enamel
OBJECTIVE- To compare the efficacy of different remineralizing potential of remeneralizing agents with the help of diagnodent fluorescence pen used in this study on white spot lesions.
REVIEW OF LITRATURE-
SeppaL , et al in (9) (1981) sodium fluoride has been an potential remineralizing agent used in early carious lesion . they showed that semi- annual application of fluoride varnishes is a caries preventive measure worth consideration even when fluoride intake from other source is optimal .
Jn ten cate (10)–(1990)he stated that fluoride is effective in sub-ppm concentration as it promotes mineral deposition and hamper mineral dissolution .the concomitment precipitation of fluoride rich mineral phase which inhibits further mineral dissolution , causes reserve of enamel demineralization , enhancement of enamel remineralization .
B.R. Schmehron , et al in (11) (2011) evaluate the success of ACP varnish as remineraling agent as it deliver significant more fluoride to both intact and demineralized enamel.
TulogluN ,et al in (12) (2016) conducted a study to investigate the effects of three fluoride varnishes with added casein phosphopeptide -amorphous calcium phosphate treatment on acid resistance of primary teeth enamel , within the limitation of this study , fluoride varnish containing CPP-ACP is more effective increasing the acid resistance of primary enamel than other fluoride varnishes.
MarijaBorisovaite, et al in (13)(2016) stated that white spot lesion can be remineralized by the use of toothpaste containing fluoride , and also observed that fluoride varnish and casein supplements were efficacious in early treatment and cessation of white spot lesion .
Mahdi Shahmoradi , et al in (14) (2017)conducted a study and evaluated that fluoride varnish with added CPP is efficient enough to protect enamel structure.he find out that the depth of lesion with no fluoride varnish was 86+_7.19 whereas depth of lesion after treated with varnish is 67+_7.03
Bayraks ,et al in (15)(2017) Conducted a study to find out that fluoride varnish with added CPP-ACP showed effective result for prevention of enamel erosion .
Kurt wolffGmbH, et al in (16) (2018) evaluated that casein phosphate due to their similar structure as enamel is very useful for daily oral health care as it resulted in remineralization of initial caries and restore small defects .
S Hekmatfar , et al in (17) (2018) conducted a study to evaluate the comparison of calcium uptake by intact enamel after using two types of CPP-ACP and stated that CPP-ACP with sodium floride have better ability to uptake calcium.
Vincenzo Tosco, et al in (1) (2020) conducted a study to evaluate effect of different remineralization agents on the enamel patten after exposure to an acid solution , and come to conclusion that CPP-ACP with sodium monoflurophosphate could represents the most effective protocol for re -establishing the intact enamel structure, given acid environment.
METHDOLOGY .
A)STUDY DESIGN- The present study is a randomised controlled clinical trial which will be conducted in the Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, King George’s Medical University Lucknow.
The rights of the patients will be protected and the parents/guardian accompanying the patients will be explained in detail about the purpose, methodology involved and the related risks and benefits, in a language well understood by them and written informed consent will be obtained. The study will be started only after the ethical approval by the Institutional Ethical Committee of King George’s Medical University, Lucknow.
MATERIALS-
· Saline
· Dry cotton gauge
· MI varnish(CPP+ACP, 5% NaF)
· Clinpro XT varnish( Resin modified glass ionomer)
· Embrace Varnish (CXP, with NaF)
B) STUDY PARTICIPANTS
Patients within age group 5-13 years , irrespective of gender and socioeconomic status will be enrolled in study.
INCLUSION CRITERIA
· The children should be in the range of 5-13 years.
· Teeth should be fully erupted (permanent incisors and canine ) with active white spot lesion with complete and intermittent tooth surface
EXCLUSION CRITERIA
· Patients who used medicaments
· Patient with orthodontic devices
· Patient who are allergic to milk
· Patients who have cavitated carious lesion or enamel defects
NUMBER OF GROUPS TO BE STUDIED, IDENTIFICATION OF GROUPS WITH DEFINATION
Informed consent will be obtained from the parents. All participants will be screened by taking a detailed history and performing a thorough clinical examination. The final selected teeth with active white spot lesion in permanent incisors and canine from the screened participants, that meet all the inclusion and exclusion criteria will be divided randomly into three groups depending upon the type of varnish used
i. GROUP 1-embrace varnish ( study group)
ii. Group 2 – clinpro XT ( study group )
iii. Group 3 – MI varnish ( control group)
C) SAMPLING
SAMPLING POPULATION
The sampling population will consist of the patients within 5-13 years of age, having teeth with active white spot lesion in permanent incisors and canine , which will be selected from the outpatient unit of the Paediatric and Preventive Dentistry Department, Faculty of Dental Sciences, King George’s Medical University, Lucknow.
SAMPLE SIZE
According to statistical calculation approximately 15 teeth shall be included in each group.
SAMPLE SIZE CALCULATION
At 90 % Power
Sample size is calculated on the basis of IQR (interquartile range) of lesion intensity in one of the study groups using the formula :
Where s = 4, The IQR of CPP-ACP + fluoride group
d = 0.3 times median lesion intensity (=19), the minimum mean difference consider to be clinically significant
(Ref.Mendes et. al.)
type I error α = 5% corresponding to 95% confidence level
type II error β = 10% for detecting results with 90% power of study
Data loss = 10%
So the required sample size
n = 15 each group
Randmisation- The patients enrolled for the study will be randomly allocated in one of the three groups by block randomization method.
D) STUDY PROCEDURE– All selected permanent teeth shall be randomly divided into three groups depending upon the type of varnish used . after clinical examination brushing and cleaning of the tooth surface is done with the help of gauze of sterile cotton , the white spot lesion is assessed with the help of Diagnodent pen (lesion having numerical score of 14 or equal to 14 or more than it ) total teeth for each study group. Depending on the type of varnish , the teeth will be treated as follows
Group 1- The embrace varnish is applied in thin and uniform layer on the tooth surface using a microbrush , varnish sets after it comes in, contact with saliva and it should remain undisturbed for 4 hrs on the teeth surface .
Group 2 – the clinpro XT varnishis applied in thin and uniform layer on the tooth surface and light cured for the 20 seconds
Group 3- the MI varnish is also applied in thin and uniform layer and should be undisturbed till 4 hour (patients is instructed not to take any antimicrobial agents during this experimental period )
OUTCOME PARAMETERS
Evaluation of remineralizing efficacy of varnishes at follow up of 1day , 1 month , and 3 months.
FOLLOW – UP TIMELINE
All outcomes shall be observed at baseline , 1 day , 1 month , 3 months post treatment for each patient.
E) DATA COLLECTION METHOD:
The data for each to oth will be recorded on individual data record sheet. The final data will be transferred to master data sheet. The data thus obtained will be subjected to statistical analysis.
F) If the clinical trial, whether the registration with CTRI will be done – Yes
G) STATICAL ANALYSIS
Data will be analysed and expressed in mean (SD) for quantitative variable and proportion/percentages for qualitative data. Categorical variables will be compared by using Chi-square test among the groups. The continuous variables will be compared by using one way analysis of variance (ANOVA) test among the groups. Other appropriate tests will be used for the statistical analysis. ‘p’ value < 0.05 will be considered significant.
REFERENCE
1. Wagle M, D’Antonio F, Reierth E, Basnet P, Trovik TA, Orsini G, et al. Dental caries and preterm birth: a systematic review and meta-analysis. BMJ Open. 2018 Mar;8(3):e018556.
2. Samuel V, Ramakrishnan M, Halawany H, Abraham N, Jacob V, Anil S. Comparative evaluation of the efficacy of tricalcium phosphate, calcium sodium phosphosilicate, and casein phosphopeptide – amorphous calcium phosphate in reducing streptococcus mutans levels in saliva. Niger J Clin Pract. 2017;20(11):1404.
3. Use of Casein Amorphous Calcium Phosphate (CPP-ACP) on White-spot Lesions: Randomised Clinical Trial. Oral Health Prev Dent. 2018 Jan 25;16(1):27–31.
4. Tosco V, Monterubbianesi R, Sparabombe S, Orilisi G, Putignano A. In Vitro Investigation of the Effect of Different Remineralizing Agents on Human Enamel. 4(3):7.
5. Ferreira JMS, Aragão AKR, Rosa ADB, Sampaio FC, de Menezes VA. Therapeutic effect of two fluoride varnishes on white spot lesions: a randomized clinical trial. :6.
6. Bapat SA, Shashikiran N, Gaugawd S, Gaonkar N, Taur S, Hadakar S, et al. In-vitro Comparison of Anti-Microbial Efficacy and Enamel Microhardness after Application of Two Types of Fluoride Varnishes. J Clin Diagn Res [Internet]. 2020 [cited 2020 Dec 16]; Available from: https://jcdr.net/article_fulltext.asp?issn=0973-709x&year=2020&volume=14&issue=4&page=ZC05&issn=0973-709x&id=13627
7. Bhat SS, Hegde KS, Rao HA, Sargod SS, Varma V. Comparative Evaluation of Remineralization Potential of Two Varnishes Containing CPP–ACP and Tricalcium Phosphate: An In Vitro Study. Int J Clin Pediatr Dent. 2019 Jun;12(3):233–6.
8. Hicks J, Garcia-Godoy F, Flaitz C. Biological factors in dental caries: role of remineralization and fluoride in the dynamic process of demineralization and remineralization (part 3). J Clin Pediatr Dent. 2004 Apr 1;28(3):203–14.
9. Seppă L, Hausen H, Tuutti H, Luoma H. Effect of a sodium fluoride varnish on the progress of initial caries lesions. Scand J Dent Res. 1983 Apr;91(2):96-8. doi: 10.1111/j.1600-0722.1983.tb00783.x. PMID: 6574585.
10. Cate JMT. In vitro Studies on the Effects of Fluoride on De- and Remineralization. 1990;69:6.
11. Schemehorn BR, Wood GD, McHale W, Winston AE. Comparison of fluoride uptake into tooth enamel from two fluoride varnishes containing different calcium phosphate sources. J Clin Dent. 2011;22(2):51-4. PMID: 21702326.
12. Tuloglu N, Bayrak S, Tunc ES, Ozer F. Effect of fluoride varnish with added casein phosphopeptide-amorphous calcium phosphate on the acid resistance of the primary enamel. BMC Oral Health. 2016 Sep 26;16(1):103. doi: 10.1186/s12903-016-0299-4. PMID: 27670292; PMCID: PMC5036284.
13. Lopatiene K, Borisovaite M, Lapenaite E. Prevention and Treatment of White Spot Lesions During and After Treatment with Fixed Orthodontic Appliances: a Systematic Literature Review. J Oral Maxillofac Res. 2016 Jun 30;7(2):e1. doi: 10.5037/jomr.2016.7201. PMID: 27489605; PMCID: PMC4970501.
14. Shahmoradi M, Hunter N, Swain M. Efficacy of Fluoride Varnishes with Added Calcium Phosphate in the Protection of the Structural and Mechanical Properties of Enamel. Biomed Res Int. 2017;2017:7834905. doi: 10.1155/2017/7834905. Epub 2017 Dec 7. PMID: 29362716; PMCID: PMC5738627.
15. Bayrak S, Tuloglu N, Bicer H, Sen Tunc E. Effect of Fluoride Varnish Containing CPP-ACP on Preventing Enamel Erosion. Scanning. 2017 Jan 9;2017:1897825. doi: 10.1155/2017/1897825. PMID: 29109803; PMCID: PMC5661827.
16. Meyer F, Amaechi BT, Fabritius HO, Enax J. Overview of Calcium Phosphates used in Biomimetic Oral Care. Open Dent J. 2018 May 31;12:406-423. doi: 10.2174/1874210601812010406. PMID: 29988215; PMCID: PMC5997847.
17. Hekmatfar S, Jafari K, Mohammadpour S. An in-vitro Comparison of Calcium Uptake by Intact Enamel after Using two Types of Casein Phosphopeptide-Amorphous Calcium Phosphate Paste. J Res Dentomaxillofac Sci. 2018; 3 (1) :6-11.
INTRODUCTION :
Dental caries remains a fundamental concern of today’s practice and continues to be one of the most common disease in the world , despite the significant progress of research and diffused home-practice of oral hygiene .the current concept of the caries forming process is based on the accumulation of numerous episodes of demineralization and remineralization , initiated by acid producing bacteria in the oral micro-environment .(1)
At the early stage of dental caries process , the relationship between pathogenic and protective factor is dynamic and thoroughly reversible(2) .
White spot lesion marks The initial stage of demineralization , which follows carious progression in enamel , which can be reversed . enamel demineralization causes loss of minerals on the outer surface which result in increase in porosity . it is considered if enamel appears rough and opaque or inactive with a smooth and shiny appearance.(3)
Conversely , remineralization occurs when the calcium, phosphate gradient invert and spread towards inside of the lesion . Natural remineralization in the initial phase is stimulated by saliva , which contains calcium ion , phosphate ion , buffer agents , fluoride and other substances . however , when this ideal condition is lacking , topical agents become essential to avoid demineralization(4).
Dental caries can be prevented by enhancing remineralization and increasing resistance of teeth to acid , Many non – invasive therapies can be used such as fluoride for controlling the progression of carious lesion.(2)
Many researches shows that fluoride varnishes can used to prevent demineralization process of an initial carious lesion as it reverse and arrests the lesion. The presence of fluoride ions in the oral cavity causes the fluorapatite to precipitate the calcium and phosphate ion existing into the saliva .the increase in PH will therefore lead to the formation of larger crystals resistant to fluorine containing acids (Fluro hydroxyapatite) , developing a strong surface layer which increase the resistance to demineralization, however products containing calcium, phosphate , phosphate and fluoride in their bio-available forms have claimed to increase remineralization over products containing only fluoride . These include fluoride varnishes with added calcium and phosphate have been introduced recently(5) .
Casein phosphopeptide (CPP) are derived from casein digestion by trypsin enzyme. Amorphous calcium phosphate (ACP) with 5% NaF are added to CPP , which is novel agent for prevention and arresting of dental caries , application of CPP-ACP along with fluoride reduce the degree of demineralization of white spot lesion in clinical study(5)
Xylitol intake leads to favorable results like low incidence of caries and S. mutans level in oral flora due to inefficiency of five carbon sugar xylitol to be fermented by S. mutans . Xylitol incorporated varnishes have shown to be favorable substitute to increase enamel remineralization (6)
And a light cure glass ionomer based resin which is also contain fluorides, calcium and phosphate which help in supplementing the remineralization process and also help in reducing dentinal hypersensitivity(7)
These topical agents show promise in their ability to prevent enamel demineralization , these are the most advanced fluoride varnishes , due to addition of calcium and phosphate ions it prevents enamel demineralization as it supplements the saliva with increased ion which in turn causes remineralization by fluoride(8)
AIM-To evaluate the remineralizing potential of remineralizing agents (MI Varnish , Clinpro XT , embrace varnish ) on white spot lesions of enamel
OBJECTIVE- To compare the efficacy of different remineralizing potential of remeneralizing agents with the help of diagnodent fluorescence pen used in this study on white spot lesions.
REVIEW OF LITRATURE-
SeppaL , et al in (9) (1981) sodium fluoride has been an potential remineralizing agent used in early carious lesion . they showed that semi- annual application of fluoride varnishes is a caries preventive measure worth consideration even when fluoride intake from other source is optimal .
Jn ten cate (10)–(1990)he stated that fluoride is effective in sub-ppm concentration as it promotes mineral deposition and hamper mineral dissolution .the concomitment precipitation of fluoride rich mineral phase which inhibits further mineral dissolution , causes reserve of enamel demineralization , enhancement of enamel remineralization .
B.R. Schmehron , et al in (11) (2011) evaluate the success of ACP varnish as remineraling agent as it deliver significant more fluoride to both intact and demineralized enamel.
TulogluN ,et al in (12) (2016) conducted a study to investigate the effects of three fluoride varnishes with added casein phosphopeptide -amorphous calcium phosphate treatment on acid resistance of primary teeth enamel , within the limitation of this study , fluoride varnish containing CPP-ACP is more effective increasing the acid resistance of primary enamel than other fluoride varnishes.
MarijaBorisovaite, et al in (13)(2016) stated that white spot lesion can be remineralized by the use of toothpaste containing fluoride , and also observed that fluoride varnish and casein supplements were efficacious in early treatment and cessation of white spot lesion .
Mahdi Shahmoradi , et al in (14) (2017)conducted a study and evaluated that fluoride varnish with added CPP is efficient enough to protect enamel structure.he find out that the depth of lesion with no fluoride varnish was 86+_7.19 whereas depth of lesion after treated with varnish is 67+_7.03
Bayraks ,et al in (15)(2017) Conducted a study to find out that fluoride varnish with added CPP-ACP showed effective result for prevention of enamel erosion .
Kurt wolffGmbH, et al in (16) (2018) evaluated that casein phosphate due to their similar structure as enamel is very useful for daily oral health care as it resulted in remineralization of initial caries and restore small defects .
S Hekmatfar , et al in (17) (2018) conducted a study to evaluate the comparison of calcium uptake by intact enamel after using two types of CPP-ACP and stated that CPP-ACP with sodium floride have better ability to uptake calcium.
Vincenzo Tosco, et al in (1) (2020) conducted a study to evaluate effect of different remineralization agents on the enamel patten after exposure to an acid solution , and come to conclusion that CPP-ACP with sodium monoflurophosphate could represents the most effective protocol for re -establishing the intact enamel structure, given acid environment.
METHDOLOGY .
A)STUDY DESIGN- The present study is a randomised controlled clinical trial which will be conducted in the Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, King George’s Medical University Lucknow.
The rights of the patients will be protected and the parents/guardian accompanying the patients will be explained in detail about the purpose, methodology involved and the related risks and benefits, in a language well understood by them and written informed consent will be obtained. The study will be started only after the ethical approval by the Institutional Ethical Committee of King George’s Medical University, Lucknow.
MATERIALS-
· Saline
· Dry cotton gauge
· MI varnish(CPP+ACP, 5% NaF)
· Clinpro XT varnish( Resin modified glass ionomer)
· Embrace Varnish (CXP, with NaF)
B) STUDY PARTICIPANTS
Patients within age group 5-13 years , irrespective of gender and socioeconomic status will be enrolled in study.
INCLUSION CRITERIA
· The children should be in the range of 5-13 years.
· Teeth should be fully erupted (permanent incisors and canine ) with active white spot lesion with complete and intermittent tooth surface
EXCLUSION CRITERIA
· Patients who used medicaments
· Patient with orthodontic devices
· Patient who are allergic to milk
· Patients who have cavitated carious lesion or enamel defects
NUMBER OF GROUPS TO BE STUDIED, IDENTIFICATION OF GROUPS WITH DEFINATION
Informed consent will be obtained from the parents. All participants will be screened by taking a detailed history and performing a thorough clinical examination. The final selected teeth with active white spot lesion in permanent incisors and canine from the screened participants, that meet all the inclusion and exclusion criteria will be divided randomly into three groups depending upon the type of varnish used
i. GROUP 1-embrace varnish ( study group)
ii. Group 2 – clinpro XT ( study group )
iii. Group 3 – MI varnish ( control group)
C) SAMPLING
SAMPLING POPULATION
The sampling population will consist of the patients within 5-13 years of age, having teeth with active white spot lesion in permanent incisors and canine , which will be selected from the outpatient unit of the Paediatric and Preventive Dentistry Department, Faculty of Dental Sciences, King George’s Medical University, Lucknow.
SAMPLE SIZE
According to statistical calculation approximately 15 teeth shall be included in each group.
SAMPLE SIZE CALCULATION
At 90 % Power
Sample size is calculated on the basis of IQR (interquartile range) of lesion intensity in one of the study groups using the formula :
Where s = 4, The IQR of CPP-ACP + fluoride group
d = 0.3 times median lesion intensity (=19), the minimum mean difference consider to be clinically significant
(Ref.Mendes et. al.)
type I error α = 5% corresponding to 95% confidence level
type II error β = 10% for detecting results with 90% power of study
Data loss = 10%
So the required sample size
n = 15 each group
Randmisation- The patients enrolled for the study will be randomly allocated in one of the three groups by block randomization method.
D) STUDY PROCEDURE– All selected permanent teeth shall be randomly divided into three groups depending upon the type of varnish used . after clinical examination brushing and cleaning of the tooth surface is done with the help of gauze of sterile cotton , the white spot lesion is assessed with the help of Diagnodent pen (lesion having numerical score of 14 or equal to 14 or more than it ) total teeth for each study group. Depending on the type of varnish , the teeth will be treated as follows
Group 1- The embrace varnish is applied in thin and uniform layer on the tooth surface using a microbrush , varnish sets after it comes in, contact with saliva and it should remain undisturbed for 4 hrs on the teeth surface .
Group 2 – the clinpro XT varnishis applied in thin and uniform layer on the tooth surface and light cured for the 20 seconds
Group 3- the MI varnish is also applied in thin and uniform layer and should be undisturbed till 4 hour (patients is instructed not to take any antimicrobial agents during this experimental period )
OUTCOME PARAMETERS
Evaluation of remineralizing efficacy of varnishes at follow up of 1day , 1 month , and 3 months.
FOLLOW – UP TIMELINE
All outcomes shall be observed at baseline , 1 day , 1 month , 3 months post treatment for each patient.
E) DATA COLLECTION METHOD:
The data for each to oth will be recorded on individual data record sheet. The final data will be transferred to master data sheet. The data thus obtained will be subjected to statistical analysis.
F) If the clinical trial, whether the registration with CTRI will be done – Yes
G) STATICAL ANALYSIS
Data will be analysed and expressed in mean (SD) for quantitative variable and proportion/percentages for qualitative data. Categorical variables will be compared by using Chi-square test among the groups. The continuous variables will be compared by using one way analysis of variance (ANOVA) test among the groups. Other appropriate tests will be used for the statistical analysis. ‘p’ value < 0.05 will be considered significant.
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