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CTRI Number  CTRI/2024/12/078582 [Registered on: 26/12/2024] Trial Registered Prospectively
Last Modified On: 26/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing Two Tooth-Colored Fillings for Molar Cavities: A Patient-Based Study on Durability and Appearance 
Scientific Title of Study   A COMPARATIVE CLINICAL EVALUATION OF TWO BIOMIMETIC COMPOSITES ON OCCLUSAL RESTORATIONS;A RANDOMIZED SPLIT MOUTH STUDY.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samiha Fathima 
Designation  PG STUDENT 
Affiliation  the oxford dental college and hospital 
Address  cluster, Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068 2nd floor room number 4 department of conservative dentistry and endodontics
#45 1st Cross Road Sri Balaji Krupa Layout RK Hegde Nagar Behind icici bank 560077
Bangalore
KARNATAKA
drsamiha fathima
India 
Phone  09739500176  
Fax  080-61754693  
Email  samihashariff24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.sri rekha A 
Designation  head of the department and guide 
Affiliation  the oxford dental college and hospital 
Address  cluster, Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068 department of conservative dentistry and endodontics.room number 4 ,2nd floor
2nd floor room number 4 department of conservative dentistry and endodontics
Bangalore
KARNATAKA
560068
India 
Phone  09739500176  
Fax  080-61754693  
Email  drsrirekha.a@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.sri rekha A 
Designation  Guide  
Affiliation  the oxford dental college and hospital 
Address  cluster, Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068
cluster, Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068 department of conservative dentistry and endodontics.room number 4 ,2nd floor
Bangalore
KARNATAKA
560068
India 
Phone  09739500176  
Fax  080-61754693  
Email  drsrirekha.a@gmail.com  
 
Source of Monetary or Material Support  
dr.samiha fathima cluster, Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068 
Dr.sri rekha A 
 
Primary Sponsor  
Name  Drsamiha fathima  
Address  cluster, Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
drsamiha fathima  the oxford dental college  cluster, Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA 		 09739500176
080-61754693
samihashariff24@gmail.com 
Drsamiha fathima  The oxford dental college,department of conservative dentistry and endodontics room number 4  Cluster, Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA 		 9739500176
080-61754693
samihashariff24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
the institutional ethics committee  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  group 1 supra nano spherical filler composite group 2 nanohybrid composite   1 month,3 months,6 month and 12 months 
Comparator Agent  group 1 supra nano spherical filler composite group 2 nanohybrid composite  The clinical performance of wear anatomy, color stability, and marginal discoloration of supra nano spherical filler composite in class I posterior carious teeth using modified USPHS criteria. ï‚· The clinical performance of wear anatomy, color stability, and marginal discoloration of nanohybrid composite in class I posterior carious teeth using modified USPHS criteria. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Patients with carious lesions in the age group 18-45 years.
2.Patients with carious lesions on the occlusal surface in posterior teeth with
remaining dentine thickness [RDT] of 1mm.
3.Absence of pain from tooth to be restored.
4.Good oral hygiene.
5. Restorations are required in two different quadrants, or at least two teeth.
6. Teeth in contact with adjacent and opposing teeth.
7.Patients who are willing to participate in the study.
 
 
ExclusionCriteria 
Details  1.Patients with pulp and periapical pathologies.
2. Patients with bruxism, attrition, and malocclusion or rotated teeth.
3. Morphological defects.
4. Teeth to be restored in contact with any cuspals coverage or crowns. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
This in vivo split-mouth study will be done at baseline,1 month, 3 months,6months,
and 12 months intervals.
The Objectives of this study will be to evaluate and compare;
ï‚· The clinical performance of wear anatomy, color stability, and marginal
discoloration of supra nano spherical filler composite in class I posterior
carious teeth using modified USPHS criteria.
ï‚· The clinical performance of wear anatomy, color stability, and marginal
discoloration of nanohybrid composite in class I posterior carious teeth using
modified USPHS criteria.
 		 baseline 1 month
3 months
6 months
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
The post-operative sensitivity in supra nano spherical filler composite and
nanohybrid composite using VAS scale at 1 week and USPHS criteria at
3,6,12 months in class I posterior carious teeth. 		 1 month,3 months,6 months,12 months 
 
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 3 
Date of First Enrollment (India)   07/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/01/2025 
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 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  

This in vivo split-mouth study aims to compare the clinical performance of two types of biomimetic composites—supra nano spherical filler composite and nanohybrid composite—in Class I posterior occlusal restorations. Over a 12-month period, 20 patients will receive restorations in two quadrants, with each quadrant randomly assigned one of the composite materials. Clinical assessments will take place at baseline, 1 month, 3 months, 6 months, and 12 months to evaluate wear anatomy, color stability, marginal discoloration, and post-operative sensitivity.

Each material’s performance will be assessed using modified USPHS criteria, while post-operative sensitivity will be evaluated via the Visual Analog Scale (VAS) and USPHS criteria at multiple time points. A total of 40 samples (20 per composite type) will be analyzed. Statistical comparisons will include t-tests, Chi-Square tests, Repeated Measures ANOVA, and Cochran’s Q test, with significance set at p < 0.05. The study’s findings aim to inform practitioners on the longevity and clinical efficacy of single-shade biomimetic composites in posterior restorations.

 
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