| CTRI Number |
CTRI/2020/06/026051 [Registered on: 23/06/2020] Trial Registered Prospectively |
| Last Modified On: |
04/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dental Crown] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Comparison Of Zirconia Crown With Glass Reinforced Fibre Composite Crown (Gfrc) |
|
Scientific Title of Study
|
Comparative assessment of the Clinical Efficacy in Zirconia crown and Glass Reinforced Composite Crown (GFRC) 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 |
403
Department of Pediatric Dentistry
2nd Floor
MARDC CAMP,
Pune
411001
Pune
MAHARASHTRA
411001
India |
| Phone |
|
| Fax |
|
| Email |
drabhinavtalekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinav Talekar |
| Designation |
Associate Professor |
| Affiliation |
M A RANGOONAWALA DENTAL COLLEGE PUNE |
| Address |
403
Department of Pediatric Dentistry
2nd Floor
MARDC CAMP,
Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
|
| Fax |
|
| Email |
drabhinavtalekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Chaudhari |
| Designation |
Postgraduation Student |
| Affiliation |
M A RANGOONAWALA DENTAL COLLEGE PUNE |
| Address |
403
Department of Pediatric Dentistry
2nd Floor
MARDC CAMP,
Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
|
| Fax |
|
| Email |
drgayatrichaudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| 403
Department of Pediatric Dentistry
2nd Floor
MARDC CAMP,
Pune |
|
|
Primary Sponsor
|
| Name |
Dr Abhinav Talekar |
| Address |
403
Department of Pediatric Dentistry
2nd Floor
MARDC 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 |
M A RANGGONAWALA DENTAL COLLEGE |
403
Department of Pediatric Dentistry
2nd Floor
MARDC CAMP,
Pune
Pune
MAHARASHTRA |
9503079151
drabhinavtalekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MCE Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Figaro Crowns |
Glass Reinforced Fibre Composite Crowns for Primary Teeth
Figaro
Texas
USA |
| Comparator Agent |
NuSmile Crowns |
Preformed Zirconia Crowns For Primary Teeth
NuSmile
Texas
USA |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
subjects requiring crown placement after endodontic treatment, multi surface restorations, fractured teeth, teeth with extensive wear and or abutment for space maintainer. |
|
| ExclusionCriteria |
| Details |
Teeth indicated for extraction, extensive mobility & root resorption and parents refusing to give consent to participate in study were excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
GFRC crown group clinical performance need to be assessed
|
one week
three months
six moths
twelve months
eighteen months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival health, staining, plaque retention, occlusal wear, parents acceptance |
one week
three months
six moths
twelve months
eighteen months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/06/2020 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Abstract of Paper in International Journal of Pediatric Dentistry Journal 2019 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This clinical trial was designed as prospective, randomized, bilateral split mouth with two groups to assess clinical performance with various criteria such as color match, time taken for clinical procedure, retention prior and after cementation, occlusal wear, staining, gingival health ,plaque retention and parents satisfaction with follow up of one week follow up(b), three month(c), six month(d), 12month (e) and 18 month(f) follow up. |