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CTRI Number  CTRI/2017/09/009829 [Registered on: 18/09/2017] Trial Registered Retrospectively
Last Modified On: 12/09/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two tooth sealing systems for preventing dental decay among twelve year old school children in Chennai. 
Scientific Title of Study   Comparison of retention among proximal sealants and adhesive system in permanent mandibular first molars of 12 year old school children in Chennai - a split mouth randomized trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Brinda B 
Designation  Post graduate student 
Affiliation  Ragas dental college and hospital 
Address  Room no .10, Department of Public Health Dentistry, Ragas dental college and hospital 2/102, East coast road, Uthandi, Chennai-600119

Kancheepuram
TAMIL NADU
600119
India 
Phone  08122182218  
Fax    
Email  brinda14b@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Madan Kumar PD 
Designation  Professor and Head  
Affiliation  Ragas dental college and hospital 
Address  Department of Public Health Dentistry,Ragas dental college and hospital 2/102, East coast road, Uthandi, Chennai-600119

Kancheepuram
TAMIL NADU
600119
India 
Phone  09841760306  
Fax    
Email  madankumar21@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Brinda B 
Designation  post graduate student 
Affiliation  Ragas dental college and hospital 
Address  Room no.10, Department of Public Health dentistry, Ragas dental college and hospital 2/102, East coast road, Uthandi, Chennai-600119

Kancheepuram
TAMIL NADU
600119
India 
Phone  08122182218  
Fax    
Email  brinda14b@gmail.com  
 
Source of Monetary or Material Support  
Ragas Dental college and hospital, 2/102, East coast road, Uthandi, Chennai - 600119 
 
Primary Sponsor  
Name  Brinda B 
Address  Post graduate student, Department of public health dentistry, Ragas Dental college and Hospital, Chennai - 600119 
Type of Sponsor  Other [Self-funded] 
 
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 
DrBrindaB  Sir Ramaswamy Mudaliar higher secondary school  High school road, Venkatapuram, Ambattur, Chennai - 600053
Thiruvallur
TAMIL NADU 
08122182218

brinda14b@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ragas Dental college and hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children aged 12 years with scoring 1 according to ICDAS II criteria for recording proximal caries in their mandibular permanent first molars.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adhesive sysytem  Optibond S 
Comparator Agent  Polyurethane dimethacrylate patch - proximal sealant  Tegaderm 3M patch 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  1. Children aged 12 years with fully erupted mandibular permanent first molars bilaterally
2. Children scoring 1 according to ICDAS II criteria for recording proximal caries in their mandibular permanent first molars
3. Children not suffering from any apparent disease.
 
 
ExclusionCriteria 
Details  1. Children whose parents do not wish to give consent.
2. Children who have enamel defects like amelogenesis imperfecta, enamel hypoplasia and dental fluorosis.
3. Children suffering from acute conditions.
4. Children undergoing orthodontic treatment.
5. Children who are under medications for any systemic illness.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Retention of the interventions  1st month , 3rd month and 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
Color match,Marginal Discoloration,Marginal adaptation,Caries formation
Anatomic form, Postoperative sensitivity,Surface roughness.
 
1st month , 3rd month and 6th month 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/09/2014 
Date of Study Completion (India) 31/08/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
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)?  

Brief Summary  

Dental Caries (Decayed tooth) is the predominant dental problem next to gum diseases. Preventive dentistry is a promising field which concentrates mainly on the providing interventions at a very early stage to protect the tooth from decay. The occurrence of tooth decay is common in-between two teeth and cleaning is difficult in these areas using regular tooth brushing techniques. In the recent times, modern dentistry has widely accepted the principles of minimal invasive treatments which advocate prevention of dental caries and preservation of the natural tooth structure to the maximum possible extent. Conservative approaches have been suggested to prevent and arrest proximal carious lesions by using newer materials such as proximal sealants, adhesives and adhesive patches. The purpose of this study is to throw light on two of the newer interventions and to identify an efficient and effective intervention to protect the inter-dental (in between two teeth) surfaces. The key point to be noted is that, success of any intervention is based primarily on how ideally and for how long it protects the tooth from decay. Hence the purpose of this study is to assess and compare the retention properties of two new interventions – Proximal sealants and adhesive system for preventing dental caries in the inter-dental surfaces of the teeth. 

The study results showed that at the end of six months adhesive system showed better retention than proximal sealant- polyurethane dimethacrylate patch.

 This will be useful for the dental practitioners to identify an effective, simple and efficient treatment option to protect the inter-dental surfaces.  

 
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