| CTRI Number |
CTRI/2024/06/068870 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Preformed Zirconia Crown Versus Preformed Bioflex Crown In 4-9 Year Old Children: A Split Mouth Randomized Clinical Trial. |
|
Scientific Title of Study
|
Comparative Evaluation Of Gingival Health, Wear Of Antagonist Tooth And Parental Satisfaction In Preformed Zirconia Crown Versus Preformed Bioflex Crown In 4-9 Year Old Children: A Split Mouth 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 VIRENDRA SHIVAJIRAO PATIL |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SINHGAD DENTAL COLLEGE AND HOSPITAL |
| Address |
403 mauli angan vishnupuram colony vadgon bk pune 4
Pune
MAHARASHTRA
411041
India |
| Phone |
9307961878 |
| Fax |
|
| Email |
vp2383155@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Jathar |
| Designation |
Professor |
| Affiliation |
Sinhgad dental college and hospital pune |
| Address |
Flat no 705 madhuli apartment near abhiruchi mall sinhgad road pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9545047035 |
| Fax |
|
| Email |
prasad.jathar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad Jathar |
| Designation |
Professor |
| Affiliation |
Sinhgad dental college and hospital pune |
| Address |
Flat no 705 madhuli apartment near abhiruchi mall sinhgad road pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9545047035 |
| Fax |
|
| Email |
prasad.jathar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sinhagad dental college and hospital Vadgon BK Pune 411041 |
|
|
Primary Sponsor
|
| Name |
virendra shivajirao patil |
| Address |
sinhgad dental college and hospital pune 411041 |
| 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 Virendra Patil |
Sinhgad dental college and hospital pune |
Department no 6 Pediatric and preventive dentistry sinhagad dental college and hospital vadgon (bk) pune 411041
Pune
MAHARASHTRA |
9307961878
vp2383155@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee sinhgad dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bioflex crown |
Bioflex crown were placed in pulectomised primary molar in chidren 4-9 yr of age
duration of study 6 months |
| Comparator Agent |
zirconia crown |
Zirconia crown were placed in pulectomised primary molar in chidren 4-9 yr of age
Duration of study 6 months |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1 Clinical criteria age group 4-9 year old
children
2 Patients undergone Pulpectomy in first or
second primary molar bilaterally
3 No mobility
4 Sound antagonist tooth
|
|
| ExclusionCriteria |
| Details |
1 Systemic disease
2 Unrestorable tooth
3 Radiographic examination reveals a
internal and external resorption
4 Patients with bruxism habit
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Is there any difference in Gingival Health, wear of antagonist tooth and Parental Satisfaction in Preformed Zirconia Crown and Preformed Bioflex Crown placed following primary tooth pulp therapy in children 4-9 year old |
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
26/06/2024 |
| 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="5"
Days="20" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vp2383155@gmail.com].
- For how long will this data be available start date provided 20-12-2024 and end date provided 20-08-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
We are comparing the two esthetics crowns in children known as zirconia crown and bioflex crown. zirconia crown is already in market for many years but it has many drawbacks such as high tooth reduction,technique sensitive and high cost. Newly launched Bioflex crowns which has unique features such as them being esthetic, semi-flexible,semi-adjustable, The Purpose
of this proposed clinical trial is to compare the success rates of both the
above-mentioned Crowns |