| CTRI Number |
CTRI/2024/05/067672 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of tooth colored and metal crown for primary teeth. |
|
Scientific Title of Study
|
Clinical and radiographic evaluation of preformed Bioflx â„¢ and stainless steel crowns on vital primary molars : A randomized controlled 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 Ashveeta Shetty |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai. |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7, Highway
Road, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9821881080 |
| Fax |
|
| Email |
ashveeta.shetty@dypatil.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parnaja Valke |
| Designation |
Postgraduate student |
| Affiliation |
Dr. D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai. |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7, Highway
Road, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9881274378 |
| Fax |
|
| Email |
valkeps@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parnaja Valke |
| Designation |
Postgraduate student |
| Affiliation |
Dr. D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai. |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7, Highway
Road, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9881274378 |
| Fax |
|
| Email |
valkeps@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai, Maharashtra, India. 400706 |
|
|
Primary Sponsor
|
| Name |
Dr DY Patil Deemed to be University School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7, Highway
Road, Nerul, Navi Mumbai |
| Type of Sponsor |
Private medical college |
|
|
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 Ashveeta Shetty |
Dr. D.Y. Patil Deemed to be University, School of Dentistry |
Postgraduate clinic, Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7, Highway
Road, Nerul, Navi Mumbai
Thane
MAHARASHTRA |
9821881080
ashveeta.shetty@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research and ethical board, D. Y. Patil Deemed to be University School of Dentistry, Navi Mumbai. |
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 |
| Intervention |
Bioflx |
The selected tooth will be restored using GIC. This will be followed by tooth preparation and cementation of the bioflx crown. the approximate time required for the procedure will be 30 mins. |
| Comparator Agent |
Stainless steel crown |
The selected tooth will be restored using GIC. This will be followed by tooth preparation and cementation of the stainless steel crown. The approximate time required for the procedure will be 30 mins. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
a) 3-9 year old under the ASA class 1
b) Primary molars with multisurface caries or wide proximal caries without clinical and radiographic signs of pulp pathology
c) Primary molars without pathological root resorption
d) Frankl’s rating score of positive or definitely positive
e) Presence of antagonist tooth
|
|
| ExclusionCriteria |
| Details |
a) Children whose parents did not give consent for participation in the study
b) Children with systemic illness OR on medicines that may alter the gingival health
c) Physiological root resorption of more than one-third of root length
d) Habit of bruxism |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proximal contact, marginal extension, occlusion, indentations on crown, retention of crown, staining of crown, gingival index, plaque index, and parental acceptability for both SSC and Bioflx crowns will be evaluated as primary outcomes |
The time points at which the evaluation will be done are 1 week, 1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The tooth wear in the opposing arch will be evaluated as secondary outcome measure. |
The evaluation will be done at 1 week, 1 month, 3 months & 6 months of follow up |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
04/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
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
|
·
The
study will involve 30 carious primary molars with wide proximal and
multisurface caries requiring full coverage crowns in children aged three to
nine years, randomly allocated to, group
1: Bioflxâ„¢ crowns and group 2: Stainless steel crowns. Following
the protocol of tooth preparation and crown placement, the clinical and
radiographic evaluation will be performed immediately after crown placement,
after 1 week, 1 month, 3 months, 6 months. The clinical evaluation will
comprise of assessing the proximal contact, marginal extension,
occlusion, indentations on crown, tooth wear in opposing arch, retention of
crown, staining of crown, gingival index, plaque index, and parental
acceptability immediately and at 6 months follow up. The radiographic
assessment will include crown evaluation and marginal adaption. |