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CTRI Number  CTRI/2018/05/014279 [Registered on: 31/05/2018] Trial Registered Retrospectively
Last Modified On: 12/06/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the filling in back teeth filled with SDR filling material in one layer and two layer technique. 
Scientific Title of Study   clinical evaluation of class I posterior restorations restored with smart dentin replacement material in bulkfil and incremental layering technique- 1 year 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  Mungara Niharika 
Designation  IIyear Post Graduate in Conservative dentistry and Endodontics 
Affiliation  Narayana Dental College and Hospital 
Address  Narayana Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Chintareddypalem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  9550453257  
Fax    
Email  niharika329@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Madhusudhana 
Designation  professor and HOD 
Affiliation  Narayana Dental College and Hospital 
Address  Narayana Dental college And Hospital, Department of Conservative Dentistry And Endodontics, Chintareddyapalem Nellore.

Nellore
ANDHRA PRADESH
524003
India 
Phone  9391046354  
Fax    
Email  drmadhuk15@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suneel kumar chinni 
Designation  Professor 
Affiliation  Narayana Dental College and Hospital 
Address  Narayana Dental College and Hospital,Professor,Dept of Conservative Dentistry and Endodontics,Chintareddypalem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  9966313666  
Fax    
Email  chinnisk@yahoo.com  
 
Source of Monetary or Material Support  
Narayana Dental College And HospitalChintareddypalem,Nellore 
 
Primary Sponsor  
Name  Narayana Dental College and Hospital 
Address  Narayana Dental College and Hospital, Post Graduate Student, Department of Conservative Dentistry and Endodontics, Chintareddypalem, 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 Mungara Niharika  Narayana Dental College and Hospital  Narayana Dental College and Hospital,First Floor,Room num 4,Dept of Conservative Dentistry and Endodontics,Chintareddypalem,Nellore
Nellore
ANDHRA PRADESH 		 9550453257

niharika329@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  SMART DENTIN REPLACEMENT POSTERIOR LIGHT CURE COMPOSITE  CLASS I COMPOSITE RESTORATION WITH SMART DENTIN REPLACEMENT IN BULKFIL TECHNIQUE. 
Comparator Agent  SMART DENTIN REPLACEMENT POSTERIOR LIGHT CURE COMPOSITE  CLASS I COMPOSITE RESTORATION WITH SMART DENTIN REPLACEMENT IN INCREMENTAL TECHNIQUE 
 
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.Good oral hygiene
3. Normal occlusion
4. Occlusal caries with ICDAS code 4 and 5
 
 
ExclusionCriteria 
Details  1.Patients with fewer than 20 teeth
2.History of Existing tooth sensitivity
3.Poor ral hygiene.
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 SMART DENTIN REPLACEMENT COMPOSITE MATERIAL IN CLASS I RESTORATIONS WITH FDI CRITERIA   6 months, 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
Longevity of the restoration  6months 12 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   28/04/2016 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
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. Resin composites have been extensively employed in the restorative dentistry for more than four decades. Since 1980, light-activated composite materials are commonly used for tooth-colored restorations.However, light-activated composites are time-consuming and technique sensitive restorative material and placement of the restoration can be stressful experience Time-saving restorative materials are an ongoing demand for posterior applications. A new resin based composite (RBC) material class, the bulk-fill RBCs, has been introduced in the past few years. They are an attempt to speed up the restoration process by enabling up to 4- or 5-mm thick increments to be cured in one step, thus skipping the time-consuming layering process.Literature says that 2mm layering technique increases the polymerazition and longevity of the restoration.
                                                   Recently, a new type of flowable composite has been launched in Europe (SDRTM Smart Dentin Replacement; DENTSPLY DeTrey, Konstanz, Germany); unlike conventional flowable materials, it is characterized by incremental filling up to 4mm with minimal polymerization stress. SDRTM material have self leveling feature that allows intimate adaption to prepared cavity walls. it is designed to be overlayered with a universal composite .
                                                       The aim of this clinical study is to determine the clinical performance of SDR smart dentin replacement in class I restorations over a time period of 1 year by using bulkfill technique in one group and incremental technique in other group.
 
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