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CTRI Number  CTRI/2024/06/069365 [Registered on: 21/06/2024] Trial Registered Prospectively
Last Modified On: 29/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized Factorial Trial 
Public Title of Study   study for checking clinical evaluation and patient acceptance by using three different matrix system for class II restoration in primary molars. 
Scientific Title of Study   Comparative analysis of clinical efficacy and patient acceptance using three different matrix systems for class II restoration in primary molars .  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayyanki Mounika 
Designation  Post graduate 
Affiliation  SRI SAI COLLEGE OF DENTAL SURGERY 
Address  Department of Pediatric and Preventive Dentistry Room No 9 1-2-64/1 and 2,kothrepally,opposite shiv sagar lake,Vikarabad,Telangana-501102 India

Hyderabad
TELANGANA
501102
India 
Phone  7989582819  
Fax    
Email  ayyankimounika07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ziauddin mohammad 
Designation  PROFESSOR 
Affiliation  SRI SAI COLLEGE OF DENTAL SURGERY 
Address  Department of Pediatric and Preventive Dentistry Room No 9 1-2-64/1 and 2,kothrepally,opposite shiv sagar lake,Vikarabad,Telangana-501102 India

Hyderabad
TELANGANA
501102
India 
Phone  9885998842  
Fax    
Email  drziamohammad@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr ziauddin mohammad 
Designation  PROFESSOR 
Affiliation  SRI SAI COLLEGE OF DENTAL SURGERY 
Address  Department of Pediatric and Preventive Dentistry Room No 9 1-2-64/1 and 2,kothrepally,opposite shiv sagar ,Vikarabad ,Telangana .

Hyderabad
TELANGANA
501102
India 
Phone  9885998842  
Fax    
Email  drziamohammad@gmail.com  
 
Source of Monetary or Material Support  
Sri Sai College of Dental Surgery, Department of Pediatric and Preventive Dentistry, Room No 9, 1-2-64/1 and 2,kothrepally,opposite shiv sagar lake,Vikarabad,Telangana-501102 India 
 
Primary Sponsor  
Name  Ayyanki mounika 
Address  Sri Sai College Of Dental Surgery Department Of Pediatric And Preventive Dentistry Room No 9, 1-2-64/1&2,kothrepally,opposite shiv sagar lake,Vikarabad,Telangana -501102 India. 
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 Ayyanki Mounika  SRI SAI COLLEGE OF DENTAL SURGERY  Department of Pediatric And Preventive Dentistry Room no.9,1-2-64/1&2,kothrepally ,opposite shiv sagar lake , Vikarabad, Telangana 501102 Hyderabad Telangana .
Hyderabad
TELANGANA 
7989582819

ayyankimounika07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE 2023-24  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 
Comparator Agent  NIL  NIL 
Intervention  Restoring Class II With MODIFIED T -BAND  Comparing clinical efficacy of restoration before and after using Modified T -BAND for class 2 preparation with aid of radiographic examination . 
Intervention  Restoring Class II With PRO MATRIX -CURVE   Comparing clinical efficacy of restoration before and after using Pro matrix - curve for class 2 preparation with aid of radiographic examination 
Intervention  Restoring class II With T BAND   Comparing clinical efficacy of restoration before and after using T band for class 2 preparation with aid of radiographic examination 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children with class II caries limited to enamel or dentin and presence of adjacent teeth are included in the study.
No history of pain or swelling.
Children with positive and definitely positive behaviour are included in the study.
Both maxillary and mandibular primary first and second molars are included .
Proximal surfaces - DO of primary first molars and MO of primary second molars are included .
 
 
ExclusionCriteria 
Details  Teeth with pre shedding mobility.
Extensively damaged teeth.
Children with partially or ectopically erupted primary molars.
Children with known systemic disorders. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of conventional T-band , modified T-band and (PRO MATRIX) Curve band on clinical and patient acceptance in restoration of class II cavity .  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   05/08/2024 
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="7"
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  

 Primary teeth play a crucial role in mastication, speech development, and maintaining space for permanent dentition. Class II cavities, involving proximal surfaces, are one of the most common types of dental caries in primary dentition. The restoration of these cavities is essential to prevent further decay, maintain tooth function,  preserve the arch length and promote oral health.

Matrix bands are essential tools in class II restorations, providing support and shaping during placement of restorative material. However, achieving optimal contact points remains challenging, as inadequate contacts can lead to issues such as food impaction, periodontal problems, and tooth movement. These matrix systems are particularly useful for restoring cavities with missing proximal walls.

The primary purpose of a matrix band is to compensate for missing walls and contain filling material.  As matrix band systems have evolved, newer designs aim to improve usability and address shortcomings of older systems.

Conventional T-band placement has been a longstanding technique in pediatric dentistry for restoring class II cavities.  It involves the use of metal bands to achieve proper isolation and adaptation during the restoration process. However, this technique may have limitations.

The modified design allows for better adaptation to the tooth surface, resulting in improved marginal seal and reduced risk of micro leakage.

 The modified T-band design provides increased stability during restoration procedures, minimizing the likelihood of displacement or movement during placement of restorative materials.

 In recent years, the (PRO MATRIX) Curve band system has gained popularity as an alternative to conventional T-bands. This system utilizes a flexible, contoured matrix that adapts closely to the tooth anatomy, providing improved isolation and contouring for composite restorations. (PRO MATRIX) Curve band  aims to simplify the restoration process.

 
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