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CTRI Number  CTRI/2025/08/093145 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   clinical evaluation of two different tooth colored restorative materials 
Scientific Title of Study   Clinical performance of a nano-ceramic composite resin and a resin-modified glass ionomer restorative in Class-I occlusal cavities: A Randomised 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  Devaguptapu Anusha  
Designation  Student  
Affiliation  Gitam dental college and hospital  
Address  Department of Conservative Dentistry and Endodontics,Room no-4, 1st floor Gitam dental college and hospital Rushikonda Visakhapatnam-530045 Andhra Pradesh India Rushikonda Visakhapatnam

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  95732473313  
Fax    
Email  danusha0211@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Ravichandra Ravi 
Designation  Professor 
Affiliation  Gitam dental college and hospital  
Address  Department of Conservative Dentistry and Endodontics,Room no-4, 1st floor Gitam dental college and hospital Rushikonda Visakhapatnam-530045 Andhra Pradesh India

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  9155717777  
Fax    
Email  raavi.ravi13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Ravichandra Ravi 
Designation  Professor 
Affiliation  Gitam dental college and hospital  
Address  Department of Conservative Dentistry and Endodontics,Room no-4, 1st floor Gitam dental college and hospital Rushikonda Visakhapatnam-530045 Andhra Pradesh India

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  9155717777  
Fax    
Email  raavi.ravi13@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics,Room no-4, 1st floor Gitam dental college and hospital Rushikonda Visakhapatnam-530045 Andhra Pradesh India  
 
Primary Sponsor  
Name  Devaguptapu Anusha  
Address  Department of Conservative Dentistry and Endodontics,Room no-4, 1st floor Gitam dental college and hospital Rushikonda Visakhapatnam-530045 Andhra Pradesh 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 
Devaguptapu Anusha  Gitam dental college and hospital   Department of Conservative Dentistry and Endodontics,Room no-4, 1st floor Gitam dental college and hospital Rushikonda Visakhapatnam-530045 Andhra Pradesh India
Visakhapatnam
ANDHRA PRADESH 		 9573247313

danusha0211@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee of Gitam dental college and hospital   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  Nano-ceramic composite resin  clinical evaluation made at baseline,6 months and 1 year 
Comparator Agent  NIL  NIL 
Comparator Agent  Resin modified GIC  clinical evaluation made at baseline,6 months and 1 year 
Intervention  Two different restorative material( nanoceramic composite and resin modified GIC)  Comparison of clinical performance made at baseline,6 months and 1 year 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with no serious systemic diseases.
Patient of atleast moderate carious lesions.
Vital teeth with caries on occlusal surface.
Teeth having proper occlusal contact with the antagonist teeth. 
 
ExclusionCriteria 
Details  Teeth with chronic periodontal and gingiva inflammation.
Patients with a history of bruxism.
Teeth that are non cariously destroyed like attrited,eroded or abraded 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the clinical performance of two different posterior restorative materials using FDI criteria.  baseline (0 months) 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the clinical performance of two different posterior restorative materials using FDI criteria.  6 months, 1 year 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 3 
Date of First Enrollment (India)   25/08/2025 
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="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   Forty patients with age group between 20-50 Years who are having atleast two posterior teeth in two different quadrants with moderate carious lesions will be recruited in the study. The teeth prepared with occlusal cavities will be divided in two groups. Restoration survival and clinical performance will be evaluated at Baseline, 6 months and 12 month visits. 
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