| CTRI Number |
CTRI/2018/11/016375 [Registered on: 16/11/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measuring of changes in bite in children following placement of steel caps on decayed back teeth |
|
Scientific Title of Study
|
Evaluation of changes in the occlusion and occlusal vertical dimension in children following the placement of preformed metal crowns using Hall technique |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rose Maria Joseph |
| Designation |
Post Graduate student, |
| Affiliation |
Manipal College Of Dental Sciences |
| Address |
Department of Pedodontics and preventive dentistry,Room no:5,Manipal College Of Dental Sciences,Light House Hill road,Mangalore,Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
rosemaria3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin P Rao |
| Designation |
Associate Professor |
| Affiliation |
Manipal College Of Dental Sciences |
| Address |
Department of Pedodontics and Preventive dentistry,Room no: 5,Manipal College Of Dental Sciences,Light House Hill road,Mangalore,Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
ashwin.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rose Maria Joseph |
| Designation |
Post Graduate student |
| Affiliation |
Manipal College Of Dental Sciences |
| Address |
Department of Pedodontics and Preventive Dentistry,Room no:5, Manipal College Of Dental Sciences,Light House Hill road,Mangalore,Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
rosemaria3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pedodontics and Preventive Dentistry,Room no:5,Manipal College Of Dental Sciences,Light House Hill road,Mangalore |
|
|
Primary Sponsor
|
| Name |
Manipal College Of Dental Sciences |
| Address |
Light House Hill Road,Mangalore,Karnataka,575001 |
| Type of Sponsor |
Private medical college |
|
|
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 Rose Maria Joseph |
Manipal College Of Dental Sciences |
Department of Pedodontics and Preventive Dentistry,Room no:5,Light House Hill road,Mangalore,575001
Dakshina Kannada
KARNATAKA |
7899799370
rosemaria3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Manipal College Of Dental Sciences,Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hall technique |
Preformed metal crowns placed on primary first molars using Hall technique |
| Comparator Agent |
preoperative and post operative values of overbite and occlusal vertical dimension |
comparison of pre and post operative values of overbite and occlusal vertical dimension |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Class 1 and 2 dentinal caries that are asymptomatic
Primary first molars
Two thirds of root should be present |
|
| ExclusionCriteria |
| Details |
Symptoms of pulpal and periapical pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overbite and occlusal vertical dimension |
At weekly interval for four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overbite and occlusal vertical dimension |
1 week,2 week,3 week |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2017 |
| Date of Study Completion (India) |
28/09/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hall technique involve restoring decayed primary molars by cementing a stainless steel crown on the affected tooth without any tooth preparation.This technique has gained more popularity in the recent years as it minimises child discomfort in the dental operatory.It also improves restoration longevity as suggested by the studies condunted on this technique. Since occlusal reduction is not done while restoring primary molar a raise in the bite will be present after crown placement using this technique which is of some concern.The purpose of this study is to evaluate this occlusal changes following this technique in 44 children for one month. |