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CTRI Number  CTRI/2024/10/075491 [Registered on: 18/10/2024] Trial Registered Prospectively
Last Modified On: 21/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the performance of two different materials and sensitivity of tooth after filling the tooth with secondary caries using composite. 
Scientific Title of Study   Comparative Evaluation Of Interproximal Contact And Postoperative Sensitivity Of Permanent Mandibular Molar Restored With Composite Using Bioclear Matrix System Over Palodent V3- A Clinical Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shabnam CV  
Designation  Junior Resident  
Affiliation  Government Dental College Kozhikode  
Address  Department of Conservative Dentisrty And Endodontics Room No 60 Government Dental College Kozhikode, Kerala

Kozhikode
KERALA
673008
India 
Phone  8075602436  
Fax    
Email  shabnam3465@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayasree S 
Designation  Head Of The Department  
Affiliation  Government Dental College Kozhikode  
Address  Room no 60 Department of Conservative Dentisrty And Endodontics Government Dental College Kozhikode

Kozhikode
KERALA
673008
India 
Phone  9447276940  
Fax    
Email  jsree21@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Jayasree S 
Designation  Head Of The Department  
Affiliation  Government Dental College Kozhikode  
Address  Room no 60 Department of Conservative Dentisrty And Endodontics Government Dental College Kozhikode

Kozhikode
KERALA
673008
India 
Phone  9447276940  
Fax    
Email  jsree21@yahoo.in  
 
Source of Monetary or Material Support  
Government Dental College, Kozhikode, Kerala  
 
Primary Sponsor  
Name  Shabnam C V  
Address  Department of Conservative Dentisrty And Endodontics, Room NO 60,Government Dental College,Government Medical College P.O,673008,Kozhikode,Kerala  
Type of Sponsor  Other [SELF] 
 
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 
Shabnam C V   Government Dental College Kozhikode   Department of Conservative Dentisrty And Endodontics, Room no 60,Government Dental College,Government Medical College PO,Kozhikode,Kerala
Kozhikode
KERALA 		 8075602436

shabnam3465@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Dental College Kozhikode   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bioclear Matrix System  Evaluation Of Interproximal Contact And Postoperative Sensitivity At The Start Of the Study And After 1 And 6 Months 
Comparator Agent  Palodent V3 Matrix System  Evaluation Of Interproximal Contact And Postoperative Sensitivity At The Start Of the Study And After 1 And 6 Months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Permanent mandibular first molars which have supra gingival mesio-occlusal carious lesions representing 3 and 4 according to ICDAS II criteria, depth of cavity not extending beyond half the depth of dentin,Patients with good oral hygiene, no spacing or crowding and healthy periodontium, teeth with adequate contact with adjacent teeth.  
 
ExclusionCriteria 
Details  Patient with complex class II cavities, poor oral hygiene, spacing or crowding or any evidence of periodontal disease, Partially erupted teeth, teeth with orthodontic bands, Patients with parafunctional habits, teeth with open contacts, previously restored teeth.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the interproximal contact and postoperative sensitivity in permanent mandibular molars using composite with Palodent V3 and Bioclear matrix system.   6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Proximal contacts will be checked according to the revised FDI criteria at baseline, one month and six months, post-operative sensitivity using 10cm visual analog scale at 24hrs,1 week and one month.  24 hours to 6 months. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/10/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Requested data will be mailed

  6. For how long will this data be available start date provided 30-09-2025 and end date provided 30-09-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The proximal contact protects the stomatognathic system as well as the periodontium against damage.Two issues when recreating the proximal surface are contact tightness and surface contour.This study is to compare the interproximal contact and postoperative sensitivity of permanent mandibular molar restored with composite using two different sectional matrix systems- Palodent V3 and Bioclear biofit HD posterior.The study duration is 18 months from the date of Ethical clearance.  
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