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CTRI Number  CTRI/2019/11/022140 [Registered on: 25/11/2019] Trial Registered Prospectively
Last Modified On: 20/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of two toothpastes on microorganisms in orthodontic patients 
Scientific Title of Study   Comparison of the antimicrobial effect of Chlorhexidine digluconate toothpaste and Colgate Total toothpaste on the Streptococcus mutans levels in orthodontic patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deeksha S Innanje 
Designation  post graduate student 
Affiliation  SDM college of Dental Sciences and Hospital 
Address  41,"SURYA",Madhura estate ,keshwapur, Hubli
sattur, Dharwad
Dharwad
KARNATAKA
580023
India 
Phone  8762722888  
Fax    
Email  deekshainnanje@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deeksha S Innanje 
Designation  post graduate student 
Affiliation  SDM college of Dental Sciences and Hospital 
Address  41,"SURYA",Madhura estate ,keshwapur, Hubli
sattur, Dharwad
Dharwad
KARNATAKA
580023
India 
Phone  8762722888  
Fax    
Email  deekshainnanje@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shrinivas M Basavaraddi 
Designation  professor 
Affiliation  SDM college of Dental Sciences and Hospital 
Address  SDM college of Dental Sciences and Hospital,sattur,dharwad
SDM College of dental sciences and hospital sattur, Dharwad
Dharwad
KARNATAKA
580009
India 
Phone  9449824324  
Fax    
Email  drshrinivas6@gmail.com  
 
Source of Monetary or Material Support  
S D M College of Dental Sciences and Hospital, Sattur, Dharwad - 580009, Karnataka, India. 
 
Primary Sponsor  
Name  Dr Deeksha S Innanje 
Address  Department of Orthodontics and Dentofacial Orthopaedics S D M College of Dental Sciences and Hospital, Sattur, Dharwad - 580009, Karnataka, India. 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deeksha S Innanje  S D M College of Dental Sciences and Hospital  Room No 5, Department of Orthodontics and Dentofacial Orthopaedics, S D M College of Dental Sciences and Hospital, Sattur, Dharwad - 580009, Karnataka, India. Dharwad KARNATAKA
Dharwad
KARNATAKA 
8762722888

deekshainnanje@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, S D M College of Dental Sciences and Hospital, Dharwad, Karnataka, India.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No significant medical history 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chlorhexidine Gluconate toothpaste  Chlorhexidine Gluconate solution containing 0.004% w/w will be applied pea size twice a day for a period of 1 month 
Comparator Agent  Colgate Total toothpaste  0.3% triclosan, 2% copolymer and 0.243% sodium fluoride will be applied pea size for a single use ,twice a day for a period of one month 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  (1) Healthy patients (both genders) in the group of 14 to 25 years.
(2) Patients requiring fixed orthodontic treatment (MBT, 0.022– in slot; 3M Unitek,Monrovia,Calif).
(3) Patients with good general health (no significant medical history or drug use in the last month).
(4) Patients with permanent dentition.
(5) Patients without any periodontal diseases.
 
 
ExclusionCriteria 
Details  (1) Patients on systemic consumption of antibiotics or anti-inflammatory medications taken during the period of the study.
(2) Patients with systemic diseases such as hormonal imbalances and bone diseases.
(3) Patients with periodontal diseases.
(4) Patients with carious or infiltrated restorations.
(5) Patients with fractured teeth or presence of erosion.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Streptococcus mutans count  samples will be collected on the day of allocation of toothpaste group and next sample will be taken after a month 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque  samples will be collected on the day of allocation of toothpaste group and next sample will be taken after a month 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Publication will be done in an Indexed and peer - reviewed Journal. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   need for the study:

The primary goal of dentistry is prevention of caries and periodontal disease.1 Great changes occur in the oral biofilm, resulting from the increase in retention niches of the orthodontic appliances.2-4 The patient might be predisposed to clinical and inflammatory alterations in the periodontal tissues, as the oral cavity is colonized by supragingival biofilm and bacteria that normally inhibit the gingival sulcus.5 When basic oral hygiene is poor, orthodontic appliances create areas of plaque stagnation, especially around brackets, bands, wires, and other attachments; this facilitates the development of white spot lesions.6 Levels of acidogenic bacteria , present in the plaque, notably Streptococcus mutans, are higher in orthodontic patients than non-orthodontic patients.7,8 This causes demineralization around the brackets and leads to white spot lesions. They are most prevalent around the cervical region of the bands in the posterior region, whereas in the anterior region, the lateral incisors in both arches, followed by the canines, are the most commonly affected.6

By interruption, reduction, or elimination of the microorganisms, the dental microbial film can be controlled.9 Dentifrices help in the removal of dental microbial biofilm and antimicrobial agents are excellent vehicles for the release of therapeutic substances.10 The most common way of controlling caries is removal of the dental microbial biofilm mechanically by tooth brushing with dentrifices.11  However, patients have difficulty in maintaining an acceptable level of oral hygiene, which is difficult to achieve by the mechanical method. Therefore, as supplements to traditional cleaning methods, antimicrobial agents are being incorporated into mouthwash solutions and dentrifices.12

Dental caries is strongly associated with Streptococcus mutans, while Lactobacilli are mainly associated with the progression of the carious lesion. Hence, the presence of these microorganisms at high levels indicates an increased risk of caries.13

The use of chlorhexidine digluconate toothpaste reduces the number of Streptococcus mutans dramatically which is highly sensitive to chlorhexidine in teenagers of a general population.13

The action of chlorhexidine mouthwashes has been reported in several studies.13 Nevertheless, there are no reports in the literature about chlorhexidine digluconate toothpaste in patients with fixed orthodontic appliances. Therefore, the aims of the study are to verify the antibacterial effect of the chlorhexidine digluconate toothpaste through clinical biofilm disclosure, and to quantify Streptococcus mutans in orthodontic patients.

null hypothesis:

There is no effect of chlorhexidine digluconate toothpaste and Colgate total toothpaste on Streptococcus mutans level around the orthodontic brackets.

research hypothesis:

 There is a definite effect of chlorhexidine digluconate toothpaste and Colgate total toothpaste on Streptococcus mutans level around the orthodontic brackets.

 source of the data:

Patients whose orthodontic treatment involves extraction of 4 first premolars will be recruited from the Department of Orthodontics and Dentofacial Orthopaedics of SDM College of Dental Sciences, Dharwad, Karnataka, India.

Informed consent will be obtained from the patients in the study. This research is designed as a prospective clinical study. 

Sample size: The total sample comprises of 44 patients.

The inclusion criteria will be –

(1)   Healthy patients (both genders) in the group of 14 to 25 years.

(2)   Patients requiring fixed orthodontic treatment (MBT, 0.022– in slot; 3M Unitek,Monrovia,Calif).

(3)   Patients with good general health (no significant medical history or drug use in the last month).

(4)   Patients with permanent dentition.

(5)   Patients without any periodontal diseases.

 

The exclusion criteria will be -

(1)   Patients on systemic consumption of antibiotics or anti-inflammatory medications taken during the period of the study.

(2)   Patients with systemic diseases such as hormonal imbalances and bone diseases.

(3)   Patients with periodontal diseases.

(4)   Patients with carious or infiltrated restorations.

(5)   Patients with fractured teeth or presence of erosion

method of collection of data:

The study is designed so that the sample size (44 patients) will be divided into two equal groups (group 1 and 2, each containing 22 volunteers) of both sexes, between ages of 14 and 30 years.

1.       Clinical biofilm (plaque index) will be collected, from which the standard value for each patient will be obtained. The bacterial count will be performed.

2.       For 30 days, group 1 will use chlorhexidine digluconate toothpaste, and group 2 will use the Colgate Total toothpaste.

3.       After 30 days, the plaque index will be performed again, as well as the bacterial counts.

4.      Participants will be instructed to brush their teeth in a method as shown by the researchers, twice a day, using the toothpaste and brush provided by the researchers.

5.      The plaque index will be performed in accordance with the modified plaque index of Sillness and Loe14 with scores to determine the clinical disclosure of biofilm.

6.      Plaque samples will be collected from the labial surfaces immediately surrounding the orthodontic brackets of the maxillary lateral incisors with a sterilized curette using a 4-pass technique as suggested by Pellegrini et al.15 Four passes, each along the tooth at the bracket interface at the gingival, mesial, distal, and occlusal aspects, will be used to prevent overloading of the instrument tip.

7.      Samples will be analyzed using Mitis   salivarius agar, which is the selective medium for the mutans group.

8.       Rough surface colonies will be identified as Streptococcus mutans will be counted. The results will be expressed in colony forming units.

 

Statistical Methods:
The data will be analyzed statistically with a significance level of 5%. The microbiologic evaluation will be analyzed for differences between control and treatment groups by means of two sample t test. The tests may vary depending upon the nature of results. The statistical significance level is established at P<0.05.
list of references:

1.       Santamaria M Jr, Petermann KD, Vedovello SA, Degan V, Lucato A, Franzini CM. Am J Orthod Dentofacial Orthop. 2014 Feb;145(2):198-202.

 

2.       Diamantl-Kipioti A, Gusberti FA, Lang NP. Clinical and microbiological effects of fixed orthodontic appliances. J Clin Periodontol1987;14:326-33.

 

 

3.       Atack NE, Sandy JR, Addy M. Periodontal and microbiological changes associated with the placement of orthodontic appliances.A review. J Periodontal 1996;67:78-85.

 

4.       Gwinnett AJ, Ceen RF. Plaque distribution on bonded brackets: a scanning microscope study. Am J Orthod 1979;75:667-77.

 

 

5.       Paster BJ, Boches SK, Galvin JL, Ericson RE, Lau CN, Levanos VA,et al. Bacterial diversity in human subgingival plaque. J Bacteriol 2001;183:3770-83.

 

6.       Warat Sukontapatipark, Mohammad A. El-Agroudi, Nils J. Selliseth, Kirsten Thunold, Knut A. Selvig; Bacterial colonization associated with fixed orthodontic appliances. A scanning electron microscopy study, European Journal of Orthodontics, Volume 23, Issue 5, 1 October 2001, Pages 475–484.

 

7.      Jose JE, Padmanabhan S, Chitharanjan AB. Systemic consumption of probiotic curd and use of probiotic toothpaste to reduce Streptococcus mutans in plaque around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):67-72.

 

8.      Bishara SE, Ostby AW. White spot lesions: formation, prevention and treatment. Semin Orthod 2008;14:174-82.

 

9.        Emilson CG, Krasse B. Support for implication of the specific plaque hypothesis. Scand J Dent Res 1985;93:96-104.

 

10.   Aguiar AA, Saliba NA. Toothbrushing with vegetable oil: a clinical and laboratorial analysis. Braz Oral Res 2004;18:168-73.

 

11.  Frandsen A. Mechanical oral hygiene practices. In: Loe H,Kleinman DV, editors. Dental plaque control measures and oral hygiene practices. Oxford, Washington DC: IRL Press; 1986;93-116.

 

 

 

12.   Owens J, Addy M, Faulkner J, Lockwood C, Adair R. A short-term clinical study design to investigate the chemical plaque inhibitory properties of mouthrinses when used as adjuncts to toothpastes: applied to chlorhexidine. J Clin Periodontol 1997;24:732-7.

 

13.   Fredrik Lundström, Bo Krasse; Streptococcus mutans and lactobacilli frequency in orthodontic patients; the effect of chlorhexidine treatments, European Journal of Orthodontics, Volume 9, Issue 1, 1 January 1987, Pages 109–116.

 

 

14.   J. Silness, H. Loe, Periodontal disease in pregnancy. ii. correlation between oral hygiene and periodontal condtion, Acta Odontol. Scand. 22 (1964) 121–135.

 

 

15.   Pellegrini P, Sauerwein R, Finlayson T, McLeod J, Covell DA Jr,Maier T, et al. Plaque retention by self-ligating vs elastomeric orthodontic brackets: quantitative comparison of oral bacteria and detection with adenosine triphosphate-driven bioluminescence. Am J Orthop Dentofacial Orthop 2009;135:426.e1-9.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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