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CTRI Number  CTRI/2025/03/082887 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between palodent and dual force sectional matrix system for proximal contact tightness of class II composite restorations 
Scientific Title of Study   Comparative evaluation of palodent and dual force sectional matrix systems on proximal contact tightness of class II composite restorations in adult human permanent molars- A randomised controlled clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karan Akude 
Designation  PG student 
Affiliation  Bharti vidyapeeth dental college and hospital, Navi mumbai 
Address  Room no 302, 3rd floor, Department of conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7 CBD belapur, Navi mumbai

Mumbai
MAHARASHTRA
400614
India 
Phone  08329015699  
Fax    
Email  karanakude.98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashish Jain 
Designation  Head of Department 
Affiliation  Bharti vidyapeeth dental college and hospital, Navi mumbai 
Address  Room no 302, 3rd floor, Department of conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7 CBD belapur, Navi mumbai

Mumbai
MAHARASHTRA
400614
India 
Phone  9869152905  
Fax    
Email  drakjain5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashish Jain 
Designation  Head of Department 
Affiliation  Bharti vidyapeeth dental college and hospital, Navi mumbai 
Address  Room no 302, 3rd floor, Department of conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7 CBD belapur, Navi mumbai

Mumbai
MAHARASHTRA
400614
India 
Phone  9869152905  
Fax    
Email  drakjain5@gmail.com  
 
Source of Monetary or Material Support  
Dr Karan Akude Room no 302, 3rd floor, Bharti vidyapeeth dental college and hospital, sector 7, CBD belapur, Navi mumbai 400614 
 
Primary Sponsor  
Name  Dr Karan Akude 
Address  Department of Conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7, CBD Belapur, Navi mumbai  
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 
Dr Karan Akude  Bharati Vidyapeeth Dental College and Hospital  Room no 302, 3rd floor, Department of conservative dentistry and endodontics, Bharti vidyapeeth dental college and hospital, Sector 7 CBD belapur, Navi mumbai
Mumbai
MAHARASHTRA 
8329015699

karanakude.98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for biomedical and health research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Class II caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dual Force Sectional Matrix System  Dual force sectional matrix system is a new type of system which claims to provide tight proximal contact in class II composite restorations. Dual force sectional matrix system will be adapted to restore class II composite restorations and after 7 days, contact tightness score will be recorded 
Comparator Agent  Palodent Sectional Matrix System  Palodent sectional matrix system will be adapted 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Cooperative healthy patients who are willing to participate in the study and sign the consent form.
2. ICDAS score of 3,4, and 5 (clinically).
3. ICDAS score of RA2, RA3, RB4 (radiographically).
4. Patients in the age group of 18-50 years.
5. Fully erupted first and second molars in maxillary and mandibular arch.
 
 
ExclusionCriteria 
Details  1. Diastema between posterior teeth.
2. Presence of fixed partial dentures.
3. Mobile teeth.
4. Grossly carious teeth.
5. Patients with Gingivitis and periodontitis.
6. Caries involving disto-occlusal surface of second molars in patients with absence of third molars.
7. In cases where isolation cannot be achieved.
8. Patients with high caries index.
 
 
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 
Proximal contact tightness score  Proximal contact tightness score
after 7 days of restoration 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   17/04/2025 
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="4"
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 - NO
Brief Summary  

·      A crucial component of the masticatory system is the proximal contact. Inappropriate contact can result in periodontal disorders and food impaction.

·      During amalgam restorations, condensation of amalgam creates tight proximal contact, but when placing direct posterior composite restorations, it might be challenging to establish tight proximal contact.

·      One of the primary motivations for creating high viscosity composites, or ceromers, was the belief that applying pressure to the composite resin material would have the same result.

·      However, because of the visco-elastic nature of composite resin materials, in vitro investigations demonstrate that packing high-viscous composites does not contribute to a tight proximal contact. 

·      Therefore, the knowledge and functioning of good matrix systems for class II composite restorations is imperative to achieve good proximal contacts.

·      Although widely utilised in dentistry, traditional circumferential matrix system has limitations when it comes to forming tight proximal contact. In light of this, new alternative matrix systems have been introduced in market.

·      Sectional matrix methods combined with separation rings have been shown in recent in vitro and in vivo experiments to produce proximal contact with a good tightness in class II restoration.

·      The Palodent sectional matrix system is considered gold standard in restoring class II composite restorations until now. However, newer sectional matrix system like Dual Force claims to achieve tighter contacts with clinically and technologically advanced rings, active wedges and ultra-wrap matrix bands.

·      To best of our knowledge, no study was conducted to investigate proximal contact tightness of class II composite restorations in adult permanent molars with Palodent and Dual Force sectional matrix systems.

·      Therefore, the objective of our randomised controlled trial is to compare proximal contact tightness of class II composite restorations in adult human permanent molars using Palodent and Dual Force sectional matrix system.

 
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