| CTRI Number |
CTRI/2025/08/093216 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to clinically evaluate titanium nitride coated preformed crowns and stainless steel crowns |
|
Scientific Title of Study
|
Clinical evaluation of Titanium Nitride coated preformed crowns versus Stainless steel crowns in primary teeth: A split mouth, Randomized controlled 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 |
Shreya Bhat |
| Designation |
First year Postgraduate student |
| Affiliation |
Manipal college of Dental Sciences, Manipal |
| Address |
Department of Pediatric and Preventive Dentistry
Manipal College of Dental Sciences
Madhav Nagar, Eshwar Nagar
Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9483185990 |
| Fax |
|
| Email |
shreyavbhat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Sridhar |
| Designation |
Professor |
| Affiliation |
Manipal college of Dental Sciences, Manipal |
| Address |
Department of Pediatric and Preventive Dentistry
Manipal College of Dental Sciences
Madhav Nagar, Eshwar Nagar
Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9483185990 |
| Fax |
|
| Email |
sridhar.pedo@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shreya Bhat |
| Designation |
First year Postgraduate student |
| Affiliation |
Manipal college of Dental Sciences, Manipal |
| Address |
Department of Pediatric and Preventive Dentistry
Manipal College of Dental Sciences
Madhav Nagar, Eshwar Nagar
Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9483185990 |
| Fax |
|
| Email |
shreyavbhat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 6, Department of Pediatric and Preventive Dentistry
Manipal College of Dental Sciences
Madhav Nagar, Eshwar Nagar
Manipal, Karnataka |
|
|
Primary Sponsor
|
| Name |
Shreya Bhat |
| Address |
Room no. 6, Department of Pediatric and Preventive Dentistry Manipal College of Dental Sciences Madhav Nagar, Eshwar Nagar Manipal, Karnataka |
| 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 Shreya Bhat |
Manipal college of Dental Sciences, Manipal |
Room no. 6, Department of Pediatric and Preventive Dentistry Manipal College of Dental Sciences Madhav Nagar, Eshwar Nagar Manipal, Karnataka
Udupi
KARNATAKA |
9483185990
shreyavbhat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Stainless steel crowns |
Stainless steel crowns with conventional silicon dioxide coating |
| Intervention |
Titanium nitride crowns |
TiN coating on stainless steel crowns with increased hardness |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Patients 4 to 7 years of age
Patients with Frankl behavior rating 3 and 4
Primary molar in functional occlusion with opposing tooth
Primary molar with carious lesion involving two or more surfaces
• Primary molars with at least two third root remaining
• Primary molars treated with pulpectomy and pulpotomy
|
|
| ExclusionCriteria |
| Details |
Patients with Frankl behavior rating 1 and 2
Primary molars not in functional occlusion with opposing tooth
Primary molars with complete loss of crown structure
Primary molars with less than two third root remaining
Primary molars with mobility
Patients with nickel allergy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome to be measured is Wear on opposing tooth of primary molars
with titanium nitride coated preformed crown and stainless-steel crown using Smith and Knight wear
index (1984) |
6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome to be measured is gingival health of primary molars with titanium coated preformed
crowns and stainless-steel crown using Gingival index given by Loe and Silness (1963) |
6 months and 1 year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="2"
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
|
The aim of this study is to evaluate the wear on the opposing tooth and gingival health of primary molars restored with Titanium nitride coated preformed crowns The study follows a split mouth design wherein one side of the mouth will receive a titanium nitride coated preformed crown and the contralateral tooth will receive a stainless-steel crown Primary outcome to be measured is Wear on opposing tooth of primary molars with titanium nitride coated preformed crown and stainless-steel crown using Smith and Knight wear index 1984 Secondary outcome to be measured is gingival health of primary molars with titanium coated preformed crowns and stainless-steel crown using Gingival index given by Loe and Silness 1963 Patients will be required to report for follow ups at 6th month and 12th month |