| CTRI Number |
CTRI/2021/02/031524 [Registered on: 24/02/2021] Trial Registered Prospectively |
| Last Modified On: |
24/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Efficacy in different preformed zirconia crowns for primary teeth |
|
Scientific Title of Study
|
Comparative Assessment of the Clinical Efficacy in NuSmile Zirconia Crown and Kids E Zirconia Crown in Primary Molar Teeth- Split Mouth Randomised Prospective 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 Abhinav Talekar |
| Designation |
Associate Professor |
| Affiliation |
M A RANGOONAWALA DENTAL COLLEGE PUNE |
| Address |
Kids Dental Corner
Talekar Dental Care
off no 19 Near Victory Theatre
Camp , Pune
Azam Campus
Near Golibar maidan ,
Camp
Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9503079151 |
| Fax |
|
| Email |
drabhinavtalekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinav Talekar |
| Designation |
Associate Professor |
| Affiliation |
MARDC Pune |
| Address |
Kids Dental Corner
Talekar Dental Care
off no 19 Near Victory Theatre
Camp , Pune
Azam Campus
Near Golibar maidan ,
Camp
Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9503079151 |
| Fax |
|
| Email |
drabhinavtalekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinav Talekar |
| Designation |
Associate Professor |
| Affiliation |
MARDC Pune |
| Address |
Kids Dental Corner
Talekar Dental Care
off no 19 Near Victory Theatre
Camp , Pune
Azam Campus
Near Golibar maidan ,
Camp
Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9503079151 |
| Fax |
|
| Email |
drabhinavtalekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KIDS DENTAL CORNER CAMP PUNE |
|
|
Primary Sponsor
|
| Name |
Dr Abhinav Talekar |
| Address |
Kids Dental Corner
Talekar Dental Care
off no 19 Near Victory Theatre
Camp , Pune |
| 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 Abhinav Talekar |
TALEKAR CHILDRENS DENTAL CARE |
Department Pediatric Dentistry
Off No 19
First Floor
Pune
MAHARASHTRA |
9503079151
drabhinavtalekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF MCE 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 |
| Comparator Agent |
Kids E Zirconia Crowns |
Kids E Mumbai India
Material:
preformed zirconia crowns for primary teeth with monolith zirconia
Durability: easily withstand masticatory force
Duration: one year minimum |
| Intervention |
NuSmile Crowns for Primary Teeth |
NuSmile Texas USA
material: preformed zirconia crowns injection moulding technique
Durability: easily withstand masticatory force
Duration: one year minimum
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Post Endodontic Therapy
Multi Surface Restorations
Abutment for Space Maintainer
|
|
| ExclusionCriteria |
| Details |
Root length less than 2/3rd
Teeth about to exfoliate
Teeth indicated for extraction |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tooth Wear,
Gingival Health
Staining
Parents Satisfaction
Color Match
Fracture of Crown |
1 week
3 months
6 months
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| parents satisfaction |
12 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drabhinavtalekar@gmail.com].
- For how long will this data be available start date provided 01-12-2021 and end date provided 01-12-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Comparative Assessment of the Clinical Efficacy in NuSmile Zirconia Crown and Kids E Zirconia Crown in Primary Molar Teeth- Split Mouth Randomised Prospective Study Time interval 1 week 3 months 6 months 12 months Criteria: Occlusal Wear Fracture of crown Plaque Retention Staining
|