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CTRI Number  CTRI/2024/11/076188 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 01/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of contacts and contour of class II composite restorations . 
Scientific Title of Study   A comparative evaluation of contacts and contour of class II composite restorations in permanant mandibular molars using three different matrix systems – A randomised controlled 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 Abeera V 
Designation  post graduate student 
Affiliation  government dental college and hospital,nagour 
Address  section no 117,department of conservative dentistry and endodontics,govt dental college and hospital,medical square,medical chowk nagpur,maharastra,india

Nagpur
MAHARASHTRA
440003
India 
Phone  9633726555  
Fax    
Email  abeerav915@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjusha M Warhadpande 
Designation  Professor and Head of the department 
Affiliation  government dental college and hospital,nagpur 
Address  department of conservative dentistry and endodontics,government dental college and hospital,nagpur,maharastra,440003

Nagpur
MAHARASHTRA
440003
India 
Phone  9834513896  
Fax    
Email  manjushawarhadpande@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manjusha M Warhadpande 
Designation  Professor and Head of the department 
Affiliation  government dental college and hospital,nagpur 
Address  department of conservative dentistry and endodontics,government dental college and hospital,nagpur,maharastra,440003

Nagpur
MAHARASHTRA
440003
India 
Phone  9834513896  
Fax    
Email  manjushawarhadpande@gmail.com  
 
Source of Monetary or Material Support  
government dental college and hospital, medical square,medical chowk,nagpur,maharastra,4400003 
 
Primary Sponsor  
Name  Dr Abeera V 
Address  room no 117,department of conservative dentistry and endodontics,government dental college and hospital,nagpur,maharastra,440003 
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 Abeera V  government dental college and hospital,nagpur  117,post graduate section,department of conservative dentistry and endodontics,government dental college and hospital,nagpur
Nagpur
MAHARASHTRA 		 09633726555

abeerav915@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
instituitional ethics committee,government dental college and hospital,nagpur,e  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Densply palodent V3 introkit sectional matrix system .   Tooth with class II carious lesion restored with composite resin using densply palodent V3 introkit sectional matrix system 
Intervention  Garrison Compositight 3D Fusion Sectional Matrix system.  Tooth with class II carious lesion restored with composite resin using Garrison Compositight 3D Fusion Sectional Matrix system 
Comparator Agent  Tofflemire matrix system  Tooth with class II carious lesion restored with composite resin using Tofflemire matrix system Matrix system 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Patients in the age group of 18 to 40 years.
2. Permanent mandibular molars which have supra gingival class II carious lesions (representing score 3 & score 4 according to ICDAS II criteria).
3. Patients with good oral hygiene, no spacing or crowding, and healthy periodontium.
4. Teeth having adequate contact with adjacent teeth.
5. Teeth with cavity isthmus less than one-third of intercuspal distance. 
 
ExclusionCriteria 
Details  Patients with complex class II cavities, poor oral hygiene, spacing or crowding, or any evidence of periodontal disease
2. Partially erupted teeth
3. Teeth with orthodontic bands
4. Patients with parafunctional habits.
5. Teeth with open contacts
6. Previously restored teeth 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Proximal contacts ,contour and marginal adaptation will be checked according to the revised FDI criteria ,gingival health will be analysed using loe and sillness index ,patient satisfaction will be analysed by likert scale, proximal contour and overhanging will be analysed by bitewing radiographs  baseline,one month and six months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate & compare the interproximal contacts & contour in class II composite restorations in permanent mandibular molars restored with dentsply Palodent V3 introkit sectional matrix system,Garrison Compositight 3D Fusion Sectional Matrix system & tofflemire matrix system  baseline ,one month & six months 
 
Target Sample Size   Total Sample Size="69"
Sample Size from India="69" 
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 3 
Date of First Enrollment (India)   15/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/11/2024 
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 Yet Recruiting 
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  
The proximal contacts protect the stomatognathic system as well as the periodontium against damage by providing harmony and balance. Failure to reproduce contact area will cause subsequent periodontal diseases and tooth movements. It continues to represent a great obstacle for dental practitioners to restore optimum proximal contours and contact points with resin composites restorations.The circumferential matrix systems showed significant looser proximal contacts for Class II cavities, which might be explained by the thickness of the matrix when placing a two-surface restoration . It was shown that when placing Class II resin composite restorations, the use of sectional matrix systems and separation rings resulted in tighter proximal contacts than when traditional circumferential matrix systems, without separation rings, are applied.
Palodent V3 introkit sectional matrix system is introduced which is integrated sectional matrix system from DENTSPLY that delivers easy, predictable and accurate contacts using innovative component technology.The Garrison Slick band architecture features a moderate, average curve, a great compromise between one with a more pronounced proximal convexity, such as the Triodent /Palodent Sectional matrix systems and one without any convexity at all. This allows fitment in narrow proximal areas where root proximity is more of an issue and allows placement without the need to enameloplasty the enamel of the adjacent tooth.To the best of our knowledge no study has compared contacts and contour of permanant mandibular molars Using dentsply Palodent V3 introkit sectional matrix system, Garrison Compositight 3D Fusion Sectional Matrix System and Tofflemire matrix systems for restoring class II composite restorations .Therfore the aim of this study is to evaluate  and compare contacts and contour of permanant mandibular molars Using dentsply Palodent V3 introkit sectional matrix system, Garrison Compositight 3D Fusion Sectional Matrix System and Tofflemire matrix systems for restoring class II composite restorations.
 
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