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CTRI Number  CTRI/2024/02/062937 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A clinical study to evaluate four parameters between two composite restorative materials. 
Scientific Title of Study   Comparative Evaluation of Short Fiber-Reinforced Composite and Bulk fill Resin Composite Restoration in Primary Posterior Teeth: An in Vivo Study  
Trial Acronym  IRB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prabha Shree 
Designation  Student 
Affiliation  THE OXFORD DENTAL COLLEGE BANGALORE INDIA  
Address  Department of Pediatric and Preventive Dentistry The Oxford Dental College, Hongasandra, Bommannahalli Bangalore

Bangalore
KARNATAKA
560068
India 
Phone  08210507983  
Fax    
Email  dr.prabhashree06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bharath Vardhana S 
Designation  Reader 
Affiliation  THE OXFORD DENTAL COLLEGE BANGALORE INDIA  
Address  Department of Pediatric and Preventive Dentistry The Oxford Dental College, Hongasandra, Bommannahalli Bangalore

Bangalore
KARNATAKA
560068
India 
Phone  9886588595  
Fax    
Email  bharathdentist@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prabha Shree 
Designation  Student 
Affiliation  THE OXFORD DENTAL COLLEGE BANGALORE INDIA 
Address  Department of Pediatric and Preventive Dentistry The Oxford Dental College, Hongasandra, Bommannahalli Bangalore

Bangalore
KARNATAKA
560068
India 
Phone  08210507983  
Fax    
Email  dr.prabhashree06@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry The Oxford Dental College, Hongasandra, Bommannahalli Bangalore, Karnataka 560068 
 
Primary Sponsor  
Name  Dr Prabha Shree 
Address  S-13 , 2nd floor , Prabhavathi plasma Apt, 28 Ramayana lyt, 7th main 6th cross , Garvebhavi Palya , BANGALORE 
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 Prabha Shree  The oxford dental college   4 th floor, Room number-8 , Department of Pediatric and Preventive Dentistry, Hongasandra,Bommannahalli
Bangalore
KARNATAKA 
08210507983

dr.prabhashree06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE The oxford dental college, Bommanahalli Hosur Road Bangalore 560068   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NIL 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CLASS I OCCLUSAL CARIES CAVITY PREPARATION AND COMPOSITE RESTORATION GROUP I- EVER X FLOW GROUP II- TETRIC N CERAM  Clinical evaluation between GROUP I- EVER X FLOW (GC JAPAN TOKYO) GROUP II- TETRIC N CERAM (IVOCLAR VIVADENT SCHAAN LIECHTENSTEIN) Total Duration : 30 min 
Intervention  Clinical evaluation  To evaluate the marginal adaptation of the teeth restored by the short fiber-reinforced composite and bulk-fill resin composite. To assess the post-operative sensitivity of the teeth restored by the short fiber-reinforced composite and bulk-fill resin composite. To evaluate the development of secondary caries in the teeth restored by the short fiber-reinforced composite and bulk-fill resin composite. To assess the surface texture of the teeth restored by the short fiber-reinforced composite and bulk-fill resin composite. [Modified United States Public Health Services (USPHS) Criteria] Total Duration : 30 min  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Cooperative children.
2.Vital primary molars.
3.Patients with a good likelihood of recall availability.
4.Teeth without any symptoms.
5.Class I cavities only (occlusal surface).
 
 
ExclusionCriteria 
Details  1. Medically compromised children.
2. Extensive carious lesions.
3. Suspected of any drug or restorative material allergy.
4. Potential behavioral disorders.
5. Radiographic indication of pulp involvement
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be clinically evaluated under the USPHS criteria (marginal adapatation post operative sensitivity surface texture secondary caries) by comparing the restorations done on the class I cavity between group I - Ever X Flow composite and group II-Tetric N Ceram composite  3 months & 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
The study will compare the good clinical performance between two composites materials suitable for restoring the primary molars  1 YEAR  
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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 2 
Date of First Enrollment (India)   01/03/2024 
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="1"
Months="0"
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  

Direct restorations have been largely employed to restore posterior teeth due to their low cost when compared to indirect restorations, along with acceptable clinical performance. Resin composite restorations in the high stress-bearing area led to some common failures that are secondary caries, marginal leakage, and post-operative sensitivity. To overcome the weakness of the resin composites manufacturers developed short fiber-reinforced composites (SFRC). They are dentine replacing material in posterior high stress-bearing restorations, especially molars. The material also revealed control in polymerization shrinkage stress by fiber orientation reducing the microleakage compared with that of the composites. The resin matrix contains inorganic particulate fillers and short glass fibers that provide three-directional reinforcement. Since most of the studies have focused on evaluating SFRC in permanent teeth, there are very few studies done on primary teeth. Thus, this study aims to evaluate the clinical performance (marginal adaptation, postoperative sensitivity, development of secondary caries, and surface texture) of composite restorations restored by short fiber-reinforced composite and bulk-fill resin composite.

 
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