| CTRI Number |
CTRI/2023/06/053795 [Registered on: 13/06/2023] Trial Registered Prospectively |
| Last Modified On: |
03/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Biological Preventive Dentistry |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Tooth cavity disinfetion with Chitosan solution in 5-12 year old children |
|
Scientific Title of Study
|
Clinical Evaluation of the efficacy of Phosphorylated Chitosan as Cavity Disinfectant in Carious Primary Molars |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreejeeta Dey |
| Designation |
Post graduate student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Room no.5
JSS Dental college and hospital,Mysore Bangalore road,Bannimantap,SS Nagar
Mysore
Mysore KARNATAKA 570015 India |
| Phone |
9108456886 |
| Fax |
|
| Email |
dsreej@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Seema Deshmukh |
| Designation |
Reader |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Room no.5
JSS Dental college and hospital
Mysore Bangalore road,Bannimantap,SS Nagar
Mysore
Mysore KARNATAKA 570015 India |
| Phone |
8880505064 |
| Fax |
|
| Email |
seema.pedo@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sreejeeta Dey |
| Designation |
Post graduate student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Room no.5
JSS Dental college and hospital
Mysore Bangalore road,Bannimantap,SS Nagar
Mysore
Mysore KARNATAKA 570015 India |
| Phone |
9108456886 |
| Fax |
|
| Email |
dsreej@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Sreejeeta Dey |
| Address |
Jss dental college and hospital
Department of Pediatric and Preventive Dentistry |
| Type of Sponsor |
Other [Self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sreejeeta Dey |
JSS DENTAL COLLEGE AND HOSPITAL |
Department of Pediatric and Preventive Dentistry, Room no.5
JSS Dental college and hospital,
Mysore Bangalore road, Sri Shivarathreeshwara Nagara, Bannimantap, Mysuru, Karnataka 570015 Mysore KARNATAKA |
9108456886
dsreej@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental College and Hospital Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% chlorhexidine |
Consepsis,Ultradent |
| Intervention |
Phosphorylated chitosan |
low molecular weight chitosan from Sigma aldrich
5% (w/v) of chitosan dissolved in 0.5% (v/v) acetic acid solution, followed by addition of 25 g of urea and 50 ml of N, N dimethylformamide. Then 4 ml of phosphoric acid to be added to the chitosan solution. The mixture is reacted at 1500c of 1 hour. After cooling the reaction mixture is filtered. The obtained precipitate is washed thoroughly with 40% ethanol and then dried at room temperature |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Mandibular and maxillary primary molars
2.Moderately deep cavities (ICDAS II caries score 4,5,6) limited to single-surface occlusal lesions and two-surface lesions (mesial-occlusal, MO or distal-occlusal, DO) without buccal/lingual extension
3.systemically healthy and cooperative children(Frankl scale 3 and 4)
Radiographic criteria:
4.Lesions involving enamel and not more than half the dentinal thickness with two-third of remaining root length
|
|
| ExclusionCriteria |
| Details |
1.Systemic illness
2.Patients undergoing orthodontic treatment
3.Carious lesions involving pulp with/without root resorption and mobility
4.Re-restorations/hypomineralised teeth
5.Uncooperative patients(Frankl scale 1 and 2)
Withdrawal criteria:
6.Development of allergy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess & compare the increase or decrease in bacterial activity with the use of p-chitosan & conventional chlorhexidine cavity disinfectants by measuring mean carious lesion area using fluorescence image analysis |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare the efficacy of p-chitosan cavity disinfectant with that of conventional chlorhexidine disinfectant in the retention and longevity of a dental restoration using FDI clinical scoring criteria |
6 months |
|
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/06/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental caries is the among the commonest and highly prevalent diseases worlwide affecting 486million children with primary teeth and 2.4billion adults with permanent teeth globally.According to WHO, dental caries affects 60–90 % of schoolchildren globally, mainly in developing countries resulting in pain,infections,undernutrition thereby affecting growth and development and decrease in overall quality of life.Therefore it is of utmost importance to treat effectively and prevent dental caries from progressing, at an earlier stage, to avoid all the complications.The ideal way of treating moderately affected carious tooth is by removing the bacteria by cavity preparation followed by a cement or resin-based dental restoration. However,the complete eradication of bacteria prior to insertion of restoration plays an important role in determining the longevity of the restoration and correspondingly the success of the treatment. Bacteria can remain viable on the dentinal surface even after cavity preparation. They may survive and multiply in the presence of microleakage, which may lead to pulpal irritation, risk of recurrent caries and/or postoperative sensitivity and ultimately failure of the restoration. Attempts at the complete removal of deep carious dentin, by solely mechanical means, may result in pulp exposure and gross destruction of the tooth structure. To cope up with the above drawbacks, the concept of cavity disinfection has been introduced by some authors, which involves cleansing of the cavity with antimicrobial agents prior to placement of restoration. Multiple disinfectants(CHX,NaOCl,Laser,Ozone,Propolis etc.) have been used in clinical dentistry, to reduce or eliminate bacterial load and sterilize dentin during cavity preparation. Chlorhexidine digluconate in the form of 2% aqueous solution has been widely considered as a biocompatible,effective and toxicologically safe disinfectant. Chitosan, derived from the deacetylation of chitin, obtained from the shells of marine crustaceans is a natural nontoxic, biocompatible, biodegradable polysaccharide with tested antibacterial properties. Prior studies have described the antimicrobial potential of chitin, chitosan, and their derivatives against Streptococcus mutans and other streptococci bacteria. Among these derivatives, phosphorylated chitosan(p-chitosan) exhibits bactericidal, bioabsorbable, osteoinductive, and metal chelating properties. Since phosphate groups of p-chitosan can bind calcium ions to form nucleating sites, p-chitosan would induce the formation of a calcium phosphate layer favouring remineralization of the carious lesion. The aim of the present study is to evaluate the efficacy of p-chitosan as a potential cavity disinfectant which can decrease the bacterial load in the cavity and asses using fluorescence imaging and also compare the results with that of conventional 2%chlorhexidine disinfectant in retention and longevity of restorations. |