| CTRI Number |
CTRI/2021/02/031532 [Registered on: 25/02/2021] Trial Registered Prospectively |
| Last Modified On: |
10/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of chewing ability after placement of caps/crowns by different techniques in children. |
|
Scientific Title of Study
|
Assessment of masticatory efficiency after placement of preformed crowns by various techniques in paediatric patient: An in vivo study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tayaba Silotry |
| Designation |
PG Student |
| Affiliation |
M. A. Rangoonwala College of Dental Sciences and Research Centre |
| Address |
Room no:406, Dept of Pediatric and Preventive Dentistry ,M. A. Rangoonwala College of Dental Sciences and Research Centre, 2390, KB Rd, Hidayatullah Rd, Azam Campus, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
7506606285 |
| Fax |
|
| Email |
tayaba.silotry5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tayaba Silotry |
| Designation |
PG Student |
| Affiliation |
M. A. Rangoonwala College of Dental Sciences and Research Centre |
| Address |
Room No:406 Dept. of Pediatric and Preventive Dentistry , M. A. Rangoonwala College of Dental Sciences and Research Centre, 2390, KB Rd, Hidayatullah Rd, Azam Campus, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
7506606285 |
| Fax |
|
| Email |
tayaba.silotry5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tayaba Silotry |
| Designation |
PG Student |
| Affiliation |
M. A. Rangoonwala College of Dental Sciences and Research Centre |
| Address |
Room No:406, Dept. of Pediatric and Preventive Dentistry, M. A. Rangoonwala College of Dental Sciences and Research Centre, 2390, KB Rd, Hidayatullah Rd, Azam Campus, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
7506606285 |
| Fax |
|
| Email |
tayaba.silotry5@gmail.com |
|
|
Source of Monetary or Material Support
|
| M. A Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India |
| Orophys, Bern, Switzerland |
|
|
Primary Sponsor
|
| Name |
Tayaba Silotry |
| Address |
Room No:406,Dept. of Pediatric and Preventive Dentistry, M. A. Rangoonwala College of Dental Sciences and Research Centre, 2390, KB Rd, Hidayatullah Rd, Azam Campus, Pune |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Martin Schimmel |
Freiburgstrasse 7
CH-3010 Bern |
| Dr Srinivasan Murali |
Plattenstrasse 11
CH-8032 Zurich |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ABHINAV TALEKAR |
KIDS DENTAL CORNER |
OFF NO 19, First Floor, Kumar Pavilion
East Street Camp
PUNE
Pune
MAHARASHTRA |
9503079151
drabhinavtalekar@gmail.com |
| Tayaba Silotry |
M. A. Rangoonwala College of Dental Sciences and Research Centre |
Room No:406, Dept. of Pediatric and Preventive Dentistry , M. A. Rangoonwala College of Dental Sciences and Research Centre, 2390, KB Hidayatullah Rd, Azam Campus, Camp.
Pune
MAHARASHTRA |
7506606285
tayaba.silotry5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE M.C.E. SOCIETY |
Approved |
| ETHICAL COMMITTEE M.C.E. SOCIETY |
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 |
| Intervention |
Preformed stainless steel crown (3M ESPA USA)by Hall Technique |
Preformed stainless steel crown will be cemented without any crown reduction(Hall Technique). Recall at day 1 , 1 week, 1 month and 3 months after crown cementation. |
| Comparator Agent |
Preformed stainless steel crown(3M ESPA USA) by Conventional technique
|
The preformed crowns will be cemented after crown reduction.
Recall at day 1, 1week, 1month and 3 months after crown cementation. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ICDAS code 2(for Hall Technique)
Patients receiving conventional stainless steel crown after pulpotomy, pulpectomy or restorations.
Patients belonging to the age group of 6-10 years.
|
|
| ExclusionCriteria |
| Details |
Patients with crossbite.
Patients with TMJ abnormalities.
Teeth indicated for extraction.
Teeth with extensive mobility
Teeth with advance root resorption.
Bleeding on probing around the respective tooth.
Patient not willing to be a part of the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Masticatory efficiency is altered after placement of preformed stainless steel crowns by conventional and Hall technique. |
1 week
1 month
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Masticatory efficiency returns back to normal after placement of preformed crowns by Hall and conventional technique within a few weeks. |
1 week
1 month
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sample size- 30 Group A: 15 (Stainless steel crown by conventional technique) Group B: 15 (Stainless steel crown by Hall Technique)
Procedure: Patient recruitment according to inclusion and exclusion criteria. Evaluation of masticatory efficiency by using two colour chewing gum. Placement of stainless steel crown. Evaluation of masticatory efficiency after one day, 1 week , 1month and 3month . A questionnaire will be provided at 1 month and 3 month follow up enquiring about the any symptoms of masticatory apparatus dysfucntion. |