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CTRI Number  CTRI/2015/02/005539 [Registered on: 12/02/2015] Trial Registered Retrospectively
Last Modified On: 28/08/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of clinical performance of two different types of fillings as a treatment for caries lesions a Randomized Clinical trial  
Scientific Title of Study   Clinical performance of a class I nanohybrid composite restorations with light cure glassionomer liner and flowable composite liner 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  DrSuhasiniK 
Designation  post graduate student 
Affiliation  Narayana Dental College and Hospital 
Address  Narayana Dental college and Hospital post graduate student, Dept of conservative dentistry and endodontics Chintareddy palem, Nellore
Narayana Dental college and Hospital post graduate student, Dept of conservative dentistry and endodontics Chintareddy palem, Nellore
Nellore
ANDHRA PRADESH
524002
India 
Phone  8121083483  
Fax    
Email  suhasinikrishtipati@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKMadhusudhana 
Designation  Professor and HOD 
Affiliation  Narayana Dental College and Hospital 
Address  Narayana Dental college and Hospital Professor and HOD Dept of conservative dentistry and endodontics Chintareddy palem, Nellore
Narayana Dental college and Hospital Professor and HOD Dept of conservative dentistry and endodontics Chintareddy palem, Nellore
Nellore
ANDHRA PRADESH
524002
India 
Phone  9391046354  
Fax    
Email  drmadhuk15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSuneel Kumar Chinni 
Designation  Reader 
Affiliation  Narayana Dental College and Hospital 
Address  Narayana Dental college and Hospital Reader Dept of conservative dentistry and endodontics Chintareddy palem, Nellore
Narayana Dental college and Hospital Reader Dept of conservative dentistry and endodontics Chintareddy palem, Nellore
Nellore
ANDHRA PRADESH
524002
India 
Phone  9966313666  
Fax    
Email  chinnisk@yahoo.com  
 
Source of Monetary or Material Support  
Narayana Dental College and Hospital 
 
Primary Sponsor  
Name  Narayana Dental college and Hospital 
Address  Narayana Dental college and Hospital post graduate student Dept of conservative dentistry and endodontics Chintareddy palem Nellore 
Type of Sponsor  Other [Private Dental college and Hospital] 
 
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 suhasini K  Narayana Dental College and Hospital  Narayana Dental College and Hospital, First floor Room no 6 Dept of conservative dentistry and endodontics chintareddypalem Nellore-524003
Nellore
ANDHRA PRADESH 
8121083483

suhasinikrishtipati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Narayana Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Dental caries involving enamel and dentin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LC GIC  Class I composite restoration with LC GIC liner Duration : 30 minutes 
Comparator Agent  Smart Dentin Replacement Posterior light cure flowable liner  Class I composite restoration with SDR liner Duration : 30 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Patients age group between 18 to 40 years who
require at least 2 class I restorations
2 Patients with good oral hygiene
3 Patients with Normal occlusion
4 Occlusal caries with ICDAS code (4)
 
 
ExclusionCriteria 
Details  1 Patients with fewer than 20 teeth
2 History of existing tooth sensitivity
3 Extremely poor oral hygiene with evident of
accumulation of plaque or calculus within
gingival pocket.
4 Bruxism
5 Pregnancy or Breast feeding
6 Chronic use of anti inflammatory, analgesic or
psychotrophic drugs
7 Non – Vital teeth
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical performance of Class I restorations with USPHS criteria   Clinical performance of Class I restorations with USPHS criteria at 3,6,12 months time 
 
Secondary Outcome  
Outcome  TimePoints 
Nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2014 
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)  
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  

—                             Composite restorations have become a routine procedure for class I and class II lesions. However, polymerization shrinkage and associated stresses remain a genuine problem. The physical mismatch between shrinkage prone restorative material and stiffer tooth structure may result in undesirable clinical situations such as microleakage, marginal staining, gap formation, postoperative sensitivity and enamel microcracks. Several strategies aimed at reducing polymerization shrinkage have been proposed.

—                                            Tetric N-Ceram is a light-curing, radiopaque nano-hybrid composite for restorative treatment. Resin composites based on nano technology have certain advantages such as reduced polymerization shrinkage, increased mechanical properties, better glossy retention and diminished wear.

—                                           SDRâ„¢ Smart Dentin Replacement is a one-component, fluoride-containing, visible light cured, radiopaque flowable resin composite restorative material.It is designed to be used as a base in class I and II restorations. SDRâ„¢ material has handling characteristics typical of a ―flowable composite, but can be placed in 4mm increments with minimal polymerization stress. SDRâ„¢ material has a self-leveling feature that allows intimate adaptation to the prepared cavity walls.   It is designed to be overlayed with a universal/posterior composite.— 

                                   The aim of this clinical study is to determine the clinical performance of the nano hybrid dental composite (Tetric N Ceram) in stress-bearing posterior cavities over a time period of 1 year with the use of SDR smart dentine replacement liner in one group and LC GIC liner in one group.

 

 

 
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