| CTRI Number |
CTRI/2024/03/064790 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Esthetic crowns in children |
|
Scientific Title of Study
|
Comparison of full-coronal restorations using strip crowns and CAD CAM crowns in primary maxillary incisors- A randomized clinical 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 |
DR DEEPTHI L |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry N0 14 Ramohalli cross Mysore road Kumbalgodu Bangalore 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9632868354 |
| Fax |
|
| Email |
deepthigowda229@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagarathna C |
| Designation |
Professor |
| Affiliation |
RajaRajeswari Dental College and Hospital |
| Address |
Department of pediatric and prevetive dentistry
Room no 5 RajaRajeswari dental college and hospital
Ramohalli cross Mysore road Kumbalgodu Bangalore Karnataka India 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9845581779 |
| Fax |
|
| Email |
shaanrathna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEEPTHI L |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry N0 14 Ramohalli cross Mysore road Kumbalgodu Bangalore 560074
Rajarajeswari Dental College and Hospital
Bangalore
KARNATAKA
560074
India |
| Phone |
9632868354 |
| Fax |
|
| Email |
deepthigowda229@gmail.com |
|
|
Source of Monetary or Material Support
|
| RajaRajeswari dental college and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Deepthi L |
| Address |
RajaRajeswari Dental College and Hospital
Department of Pediatric and Preventive Dentistry
No 14 Ramohalli cross Mysore road Kumbalgodu Bangalore 560074 |
| Type of Sponsor |
Other [self funded] |
|
|
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 Deepthi L |
RajaRajeswari dental college and hospital |
Department of Pediatric and Preventive Dentistry
N0.14 Ramohalli cross Mysore road Kumbalgodu Bangalore 560074
Bangalore
KARNATAKA |
9632868354
deepthigowda229@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RajaRajeswari dental college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
anterior esthetic crowns |
Strip crowns and CAD CAM crowns will be assessed at baseline,at 3 months,6 months and 12 month follow up |
| Comparator Agent |
modified USPHS criteria |
color match,marginal discoloration,marginal integrity,surface texture,post operative sensitivity,secondary caries and fracture |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children of 3-5 years of age from either gender.
Children with ECC - Carious primary maxillary incisors with involvement of minimum two surfaces, out of which one must be palatal surface and at least 2/3rd clinical crown remains after caries removal.
Children with behavior scale 3 and 4 (Wright’s modification of Frankl’s rating).
Adequate root support with no mobility.
|
|
| ExclusionCriteria |
| Details |
Primary maxillary incisors requiring pulp therapy or already pulp treated.
Presence of single surface caries.
Children with traumatic injuries.
Children with special health care needs.
Children with parafunctional habits, e.g.: bruxism.
Children with developmental anomalies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare clinical performance of esthetic full-coronal restorations in children as follows
1.Primary maxillary incisors restored with strip crowns (celluloid crown form with composite resin).
2.Primary maxillary incisors restored with custom made CADCAM composite crowns.
|
crowns will be assessed at baseline, at 3 months, at 6 months and 12 months follow up
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/04/2024 |
| 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="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomized clinical trial comparing full coronal
restorations using strip crowns and CAD CAM crowns in primary maxillary
incisors in 40 sample of children aged between 3 to 5 years with early
childhood caries. Each child will be examined and those who fulfil the
inclusion criteria will be selected and will be randomly distributed into 2
groups with 20 samples each. Appropriate
anaesthesia will be administered. Rubber dam isolation followed by caries
removal will be done. Tooth preparation will be done accordingly and strip
crowns or CAD CAM crowns will be placed. All the above samples will be assessed
for color match, marginal discoloration, marginal integrity, surface texture ,post
operative sensitivity, secondary caries and fracture, immediately after crown
placement ,at 3 months, at 6 months and 12 months follow up. The data will be subjected for statistical
analysis. |