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CTRI Number  CTRI/2025/03/083433 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Self-assessment evaluation on student performance for class IV composite restoration in dentistry  
Scientific Title of Study   Effectiveness of self-assessment on student performance on Class IV Composite resin restorations in Pre-clinical Conservative Dentistry 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Heta Vaghasia 
Designation  Postgraduate Student 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  room no 3,department of conservative dentistrt and endodntics ,Manipal College of Dental Sciences,Lighthouse Hill Road, Hampankatta

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09619419468  
Fax    
Email  hetavaghasia414@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kundabala M 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  room no 3 ,Department of conservative dentistry and endodontics Manipal College of Dental Sciences,Lighthouse Hill Road, Hampankatta

Dakshina Kannada
KARNATAKA
575001
India 
Phone    
Fax    
Email  kunda.kamath@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Heta Vaghasia 
Designation  Postgraduate Student 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  room no 3 , department of conservative dentistry and endodontics ,Manipal College of Dental Sciences,Lighthouse Hill Road, Hampankatta

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09619419468  
Fax    
Email  hetavaghasia414@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics,Manipal College of Dental Sciences,Mangalore,Karnataka-575001,India 
 
Primary Sponsor  
Name  Dr Heta Vaghasia 
Address  Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences, Mangalore, Karnataka-575001, 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 Heta Vaghasia  Manipal College of Dental Sciences,Mangalore  ROOM NO 3 , DEPART MENT OF CONSERVATIVE DENTISTRY AND ENDONDONTICS,Lighthouse hill road, opposite KMC lighthouse near brigade royal hotel, hampankatta 301, acropolis apartment
Dakshina Kannada
KARNATAKA 
09619419468

hetavaghasia414@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe Manipal college of dental sciences,manglore  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  FACULTY SCORE BY scoring guide.  FACULTY SCORING GUIDE WILL BE CALCULATED BY 2 FACULTY TO EVALUATE CLASS 4 COMPOSITE RESTORATOIONS ON TYPHODONT TEETH IN 3 SEESIONS OVER 1 MONTH 
Intervention  SELF ASSESSMENT SCORE BY SCORING GUIDE  PARTICIPATIONS WILL SELF-EVALUATE CLASS 4 COMPOSITE RESTORATION ON TYPODONT TEETH USING SCORING GUIDE IN 3 SEESIONS OVER 1 MONTH 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  The study employs a convenience sampling method. Twelve pre-clinical students (II YEAR BDS batch) are selected based on their availability and willingness to participate. Each student will be evaluated three times for SA and FA scores using 36 typodont teeth. The sample size was determined using G Power 3.1.9.4 software, assuming a 40% improvement after the third exercise, with a 95% confidence interval and 80% power. 
 
ExclusionCriteria 
Details  Students not willing to participate in study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To obtain self-assessment scores(SA) for Class IV composite restoration prepared by students using a scoring guide .
2. Obtain faculty assessment scores (FA) from two faculty members using a scoring guide.
3. Determine the correlation between self-assessment(SA) and faculty-assessment (FA) scores using appropriate statistical analysis 
To obtain self-assessment scores(SA) for Class IV composite restoration prepared by students using a scoring guide .
2. Obtain faculty assessment scores (FA) from two faculty members using a scoring guide.
3. Determine the correlation between self-assessment(SA) and faculty-assessment (FA) scores using appropriate statistical analysis
at 1 week, 2week and 3 week 
 
Secondary Outcome  
Outcome  TimePoints 
self evaluation would increse confidance among participants  1 month 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/03/2026 
Date of Study Completion (India) 31/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/03/2025 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

Following permission from institutional ethics committee the study will be initiated. The procedural steps are given in Figure 1. All  the students (n=12) who have consented to participate in the study will be given an introductory lecture about Class IV cavity restoration via PowerPoint Presentation followed by demonstration. At the end of the demonstration, the scoring guide  will be explained  for evaluation of restoration to the students  as well as evaluating faculty. Inter-examiner agreement will be calculated before initiation of the study.

During the first session, all students  will execute Class IV cavity preparation (described by Sturdevant) in the typodont maxillary central incisor tooth of the articulated jaw model (Nissen study model) using the cavity preparation armamentarium. Using a handpiece (API micromotor handpiece)with a diamond bur, class IV cavity will be prepared on the tooth creating a bevel on the incisal angle. Then  application of 37% phosphoric acid etchant (Septodont) to the prepared cavity and the bevelled edges will be done for about 30 seconds. Then etchant will be rinsed off with water and gently the tooth will be dried . Then application of  the bonding agent (Tertic N-Bond)to the etched surface. After gently air-thin the bonding agent to evaporate the solvent, it will be  light-cured for 20 seconds. Then placement of  the composite resin(Ivoclar Teratic N- Cream) in increments will be done. After  placing the first increment at the palatal aspect to form the lingual contour. Then using a Mylar strip and wedge proximal wall and contour  will be built with composite resin ensuring  a smooth finish. The composite resin will be placed  in small increments, shaping the tooth’s anatomy with each layer.  The facial surface will be built, making sure to recreate the natural contours and incisal edge. Each increment will be light cured for 20 seconds. Finishing and polishing will be carried out using disks (Shofu Super Snap Xtreme)  to give final contour  for the restoration, ensuring that the anatomical form is replicated followed by polishing to achieve a smooth and glossy surface, blending the composite resin with the natural tooth surface. Throughout the  exercises, students will perform the procedure independently.

Following  cavity restoration, students will be given an assessment sheet to enter their  scores (SA1). All teeth will be collected, labelled, and evaluated by both the grading faculty members in a blinded manner, and the average of their scores (from both the faculties) was considered the final score [Faculty Assessment Score 1 (FA1)]. These scores (SA1, FA1) will be treated as a baseline performance because they represented the student’s first experience in a practical class .Each participant will be  explained the difference in their respective SA1 from FA1 and their queries will be resolved individually by the faculty. Students will  prepare the cavities and restore them in the next 2 more sessions. Evaluation of students’  as well as  faculty members’  scores will follow the same protocol as previous ones. All the scores will be  recorded as SA2, FA2,SA3,FA3 and  tabulated on an Excel sheet and statistical analyses will be done .

 
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