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CTRI Number  CTRI/2022/06/043116 [Registered on: 09/06/2022] Trial Registered Prospectively
Last Modified On: 07/04/2024
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 and compare proximal contact tightness and contour of two different sectional matrix systems for Class 2 composite restoration. 
Scientific Title of Study   “A Comparative Evaluation of Proximal contact tightness and contour using two different sectional matrix systems in Class 2 composite restorations -A Randomized Clinical Study." 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shreya Volety 
Designation  PG student 
Affiliation  K.M Shah Dental College and Hospital 
Address  Room NO.8 Department of Conservative Dentistry and Endodontics, Sumandeep Vidyapeeth, Pipariya Road, Waghodia, Vadodara:391760

Vadodara
GUJARAT
391760
India 
Phone  9982672855  
Fax    
Email  shreyavolety19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kishan KV 
Designation  Professor and Post Graduate guide 
Affiliation  K.M Shah Dental College and Hospital 
Address  Room NO.8 Department of Conservative Dentistry and Endodontics, Sumandeep Vidyapeeth, Pipariya Road, Waghodia, Vadodara:391760

Vadodara
GUJARAT
391760
India 
Phone  8141787335  
Fax    
Email  drkishankv@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Kishan KV 
Designation  Professor and Post Graduate guide 
Affiliation  K.M Shah Dental College and Hospital 
Address  Room NO.8 Department of Conservative Dentistry and Endodontics, Sumandeep Vidyapeeth, Pipariya Road, Waghodia, Vadodara:391760

Vadodara
GUJARAT
391760
India 
Phone  8141787335  
Fax    
Email  drkishankv@yahoo.co.in  
 
Source of Monetary or Material Support  
K.M SHAH DENTAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  Shreya Volety 
Address  17/4 Gurudaat society, Waghodia Road, Vadodara:390019 
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 Shreya Volety  K.M Shah Dental College and Hospital  Room no.8,Department of Conservative Dentistry and Endodontics, K.M.Shah Dental College and Hospital Vadodara GUJARAT
Vadodara
GUJARAT 		 9982672855

shreyavolety19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  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 Biofit HD sectional matrix system  Bioclear Biofit HD sectional matrix system consists of translucent white mylar, with a placement tab that provides a rigid structure and makes the matrix easy to place. These matrix bands are contoured plastic (Mylar) sectional matrices, available in two thicknesses (BioFit Blue Matrix: 50 µm and BioFit HD matrix: 76 µm) and 3 different heights (4.5, 5.5, 6.5 mm). These transparent matrices allow for better light transmission and allegedly more efficient polymerization of the underlying resin composite. The BioFit matrix bands have a larger buccolingual wrap and can be used in cavities that are more open in a buccolingual direction. In addition, the matrix features a curved occlusal embrasure, which if the matrix is well-positioned, shortens the finishing time of the occlusal embrasure with burs or discs. 
Comparator Agent  Composi-Tight 3DXR Sectional Matrix System (Garrison’s Dental Solution)   Composi-Tight 3DXR Sectional Matrix System (Garrison’s Dental Solution) which consists of a thin metal matrix and is available in a variety of kit configurations. The sectional matrix ring of this matrix system is designed to create more tooth separation than the traditional Tofflemire/wedge combination through the application of spring tension in the interproximal space. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Unilateral Class 2 Carious lesions in
molars and premolars not extending beyond the axial line-angles and with an intact
adjacent tooth.
2.Teeth having two adjacent Class 2 carious lesions.
3.Vital permanent molars and premolars having class 2 carious lesions having no
symptoms of irreversible pulpitis. 
 
ExclusionCriteria 
Details  1.Patients with poor oral hygiene.
2. Patients with a diastema between posterior teeth as a result of any periodontal
problem.
3. Patients with severe periodontal disease and heavy bruxism with lost physiologic
contour.
4. Tooth indicated as an abutment for fixed partial denture and tooth having more
than grade 1 mobility.
5. Teeth with developmental anomaly or pathology or congenital defects. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The result will help us to know clinical outcome of matrix system that gives better proximal contact tightness and contour between Composi-Tight 3DXR
Sectional Matrix System (Garrison’s Dental Solution) and Bioclear Biofit HD sectional
matrix system in Class 2 Composite restorations  		 All samples will be taken at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2022 
Date of Study Completion (India) 19/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 19/02/2024 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Contacts and contours form an essential component of any restorative procedure. Adequate contact and contour are required for the overall functional balance of the oral architecture. The restoration should not impinge on the biological width of the tooth. It can cause problems like food lodgement and ultimately lead to bone loss. Also, open contacts can cause food lodgement which can lead to secondary caries and ultimately compromise the integrity of the restoration. Hence use of an appropriate matrix system is important. This study aims at comparing the reconstruction of proximal contact tightness and contour using Garrison’s sectional matrix system and Bioclear Biofit HD sectional matrix system for Class 2 Composite restoration. 
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