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
|
|
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
|
|
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. |