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CTRI Number  CTRI/2018/08/015410 [Registered on: 23/08/2018] Trial Registered Prospectively
Last Modified On: 26/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study done to check the efficacy of bonding material used for filling the tooth 
Scientific Title of Study   Clinical efficacy of universal adhesive for the restoration of non carious cervical lesion:A Randomized clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ranjitha G R 
Designation  Post graduate student 
Affiliation  Vokkaligara Sangha Dental College 
Address  Department of conservative dentistry room no-6, second floor Vokkaligara Sangha Dental College and Hospital ,K R road Vishveshwarapuram Bangalore
Department of conservative dentistry room no-6, second floor Vokkaligara Sangha Dental College and Hospital ,K R road Vishveshwarapuram Bangalore
Bangalore
KARNATAKA
560004
India 
Phone  9916343767  
Fax    
Email  ranjubandu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikram R 
Designation  Reader 
Affiliation  Vokkaligara Sangha Dental College 
Address  Department of conservative dentistry room no-6, second floor Vokkaligara Sangha Dental College and Hospital ,K R road Vishveshwarapuram Bangalore
Department of conservative dentistry room no-6, second floor Vokkaligara Sangha Dental College and Hospital ,K R road Vishveshwarapuram Bangalore
Bangalore
KARNATAKA
560004
India 
Phone  9986379039  
Fax    
Email  vikramgowda.dent@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ranjitha G R 
Designation  Post graduate student 
Affiliation  Vokkaligara Sangha Dental College 
Address  Department of conservative dentistry room no-6, second floor Vokkaligara Sangha Dental College and Hospital ,K R road Vishveshwarapuram Bangalore
Department of conservative dentistry room no-6, second floor Vokkaligara Sangha Dental College and Hospital ,K R road Vishveshwarapuram Bangalore
Bangalore
KARNATAKA
560004
India 
Phone  9916343767  
Fax    
Email  ranjubandu@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Vokkaligara Sangha Dental College and hospital  
Address  Vokkaligara Sangha Dental College and Hospital ,K R road, Vishveshwarapuram Bangalore 
Type of Sponsor  Private medical college 
 
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 
Ranjitha G R  Vokkaligara Sangha Dental College and Hospital  Department of conservative dentistry room no-6, second floor ,K R road Vishveshwarapuram
Bangalore
KARNATAKA 		 9916343767

ranjubandu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethical committee of vokkaligara sangha dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  non carious cervical lesions  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Self and Selective etching technique   To evaluate the bonding ability of self etch and selective etch technique for universal bonding agent used for restoring non carious cervical lesions. 
Comparator Agent  Self and Selective etching technique   To evaluate the bonding ability of universal adhesive used in self etch and selective etch mode for restoration of non carious cervical lesion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Patient requiring restoratons in the cervical region in a minimum of two sides and one tooth in each side
2. Cervical lesions with a depth of 1-3mm and width of 2-4mm
3. Patients willing to participate and sign the informed consent form
4. Subjects who have natural dentition directly opposing the test restoration.
• Patients having good oral hygiene
 
 
ExclusionCriteria 
Details  1.ndividual with a chronic systemic disease with or without oral manifestations.
2. Individual with periodontal problems.
3. Subjects with known allergy to any materials used
4. Individual with bruxism and other parafunctional habits
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Marginal staining
Sensitivity
Fracture 		 7 days
6months
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Marginal staining
Sensitivity
Fracture 		 7 days
6months
1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 2 
Date of First Enrollment (India)   29/08/2018 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Purpose: The objective of this double-blind randomized clinical trial was to evaluate the one year clinical performance of a new universal adhesive in noncarious cervical lesions (NCCLs) using the US Public Health Service (USPHS) evaluation criteria

Methods and Materials: A total of 100 restorations will be randomly placed in  patients according to the following groups: SE-et = selective enamel etching; and SET = self-etch. The composite resin will be placed and the restorations will be evaluated after one week (baseline) and at six months using and one year USPHS criteria to check the postoperative sensitivity fracture and marginal staining in non carious cervical lesions.

 
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