| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
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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 |
|
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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 . |