| CTRI Number |
CTRI/2024/03/063696 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing gums health after giving esthetic crowns (Zirconia Crown and Bioflx Crown) in children. |
|
Scientific Title of Study
|
Comparative Evaluation of Gingival Health with Preformed Zirconia Crown and Bioflx Crown in Primary Molars: A non-inferiority 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 Monica |
| Designation |
Junior Resident |
| Affiliation |
Centre for Dental Education and Research AIIMS New Delhi |
| Address |
Department of Pediatric and Preventive Dentistry
Centre for Dental Education and Research
All India Institute of Medical Sciences
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9599869321 |
| Fax |
|
| Email |
monica250295@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Prakash Mathur |
| Designation |
Professor and Head |
| Affiliation |
Centre for Dental Education and Research AIIMS New Delhi |
| Address |
Department of Pediatric and Preventive Dentistry
Centre for Dental Education and Research
All India Institute of Medical Sciences
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811955553 |
| Fax |
|
| Email |
vijaymathur7@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica |
| Designation |
Junior Resident |
| Affiliation |
Centre for Dental Education and Research AIIMS New Delhi |
| Address |
Department of Pediatric and Preventive Dentistry
Centre for Dental Education and Research
All India Institute of Medical Sciences
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9599869321 |
| Fax |
|
| Email |
monica250295@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry
Centre for Dental Education and Research
All India Institute of Medical Sciences
New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Monica self |
| Address |
Department of Pediatric and Preventive Dentistry
Centre for Dental Education and Research
All India Institute of Medical Sciences
New Delhi |
| 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 Monica |
CDER AIIMS New Delhi |
Room no. 612
6th floor
Centre for Dental Education and Research
All India Institute of Medical Sciences
New Delhi
New Delhi
DELHI |
9599869321
monica250295@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preformed Bioflx crowns |
It is an aesthetic preformed crowns, made up of hybrid resin polymer. It can be trimmed if necessary but cannot be manipulated by crimping.
While maintain cuspal inclines, occlusal surface reduction of 1-1.5 mm using a flame shaped diamond bur will be done.
Interproximal reduction will be done using a tapered fissure bur. Proximally the tooth should slightly converge towards the occlusal surface.
For buccal or lingual reduction – Little or no reduction will be done. Reduction of a prominent buccal ridge in some teeth might be necessary.
Rounding off all the line angles will be done.
For Crown adjustment – Trimming of the crown in case required using crown and bridge scissors. Slight flattening of proximal surface can be done using howes plier and slight contouring can be done using contouring pliers.
For trial fitting – Place the posterior crown from lingual to buccal, then pushing over the buccal bulge. Check margins for close cervical adaptation extending approximately 0.5 mm subgingivally. Lastly occlusion will be checked.
Crown will be luted with type I glass ionomer cement and using finger pressure cementation will be done. |
| Comparator Agent |
Preformed Zirconia crowns |
It is an esthetic preformed crown. It cannot be crimped and contoured.
Occlusal surface reduction of 1.5-2 mm using a flame-shaped diamond bur will be done by following the normal anatomic contour.
Interproximal reduction will be done using a tapered fissure bur.
For Supragingival reduction – Chamfer margin will be created all around the tooth by a reduction of 0.5-1mm.
For Subgingival reduction – Extending chamfer margin to 2mm subgingivally without ledge formation.
Then rounding off all the line angles and passive fit of the crown and occlusion will be checked.
Crown will be luted with type I glass ionomer cement and cementation using finger pressure will be done. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Primary molars indicated for full coverage restoration from Systemically apparently healthy patients in the age range of 4-8 years of either gender.
2. Primary teeth having at least two-thirds of root radiographically.
3. Primary teeth having at least one-third of crown structure.
|
|
| ExclusionCriteria |
| Details |
1. Root resorption due to any pathological reasons
2. Absence of any oral parafunctional habits in children
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the gingival health of primary molar teeth restored with preformed Zirconia crowns and preformed Bioflx crowns |
At 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate & compare the restoration failure.
2. To evaluate & compare the color change in the crown with time
3. To evaluate & compare the cavosurface marginal discoloration.
4. To evaluate & compare the opposing tooth wear.
5. To evaluate & compare the parental satisfaction of Preformed Zirconia crowns & Preformed Bioflx crowns. |
At 6 & 12 months |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
14/03/2024 |
| 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="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Bioflx crowns have been introduced as an aesthetic alternative to the existing preformed Zirconia crowns. However, there is a scarcity of clinical data pertaining to its use. Thus, this non-inferiority randomized clinical trial is planned to evaluate and compare the clinical performance of Preformed Zirconia crowns and Preformed Bioflx crowns in terms of gingival health, restoration failure, color change in the crown with time, cavosurface marginal discoloration, opposing tooth wear, and the parental satisfaction. |