| CTRI Number |
CTRI/2024/06/069660 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of bioflx crowns as an alternative to stainless steel crown as full coverage restoration after pulp therapy in primary mandibular second molars |
|
Scientific Title of Study
|
Comparative evaluation of stainless steel and bioflx crowns in mandibular second 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 |
Nishi Rakesh Joshi |
| Designation |
Post graduate student |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences, NITTE Deemed To be University |
| Address |
Room 15, 4th Floor, Department of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute Of Dental Sciences, NITTE Deemed to be University, Deralakatte, Mangalore
Dakshina Kannada
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8983333744 |
| Fax |
|
| Email |
nishi9927@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manju R |
| Designation |
Head of the Department |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences, NITTE Deemed To be University |
| Address |
Room Number 15, 4th Floor, AB Shetty Memorial Institute Of Dental Sciences, NITTE Deemed to be University, Deralakatte, Mangalore
Dakshina Kannada
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845451954 |
| Fax |
|
| Email |
hod.pedo.absmids@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nishi Rakesh Joshi |
| Designation |
Post graduate student |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences, NITTE Deemed To be University |
| Address |
Room 15, 4th Floor, Department of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute Of Dental Sciences, NITTE Deemed to be University, Deralakatte, Mangalore
Dakshina Kannada
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8983333744 |
| Fax |
|
| Email |
nishi9927@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nishi Rakesh Joshi |
| Address |
Department of Pediatric and Preventive Dentistry, 4th Floor, AB Shetty Memorial Institute Of Dental Sciences, NITTE Deemed to be University , Deralakatte, Mangalore- 575018 |
| 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 Nishi Rakesh Joshi |
AB Shetty Memorial Institute Of Dental Sciences, NITTE Deemed to be University |
Room 15, 4th floor, Department of Pediatric And Preventive Dentistry Deralakatte, Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA |
8983333744
nishi9927@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethical Committee, NITTE University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with large carious lesion undergone pulp therapy. |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioflx crowns |
bioflx crowns by Kids-E- Dental are commercially available aesthetic crowns which will be used as full coverage restoration. |
| Comparator Agent |
Stainless Steel Crowns |
Stainless Steel Crowns by 3M will be used as comparative crown for full coverage restoration |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Endodontically treated mandibular primary second molar (pulpotomy /pulpectomy) requiring full coverage restoration.
2.Healthy children with no systemic health disorders.
3.Children, whose parents have provided consent.
|
|
| ExclusionCriteria |
| Details |
1.Teeth with pathological root resorption , root caries and furcation involvement.
2.Children with parafunctional habits and TMJ disorders.
3.Teeth with inadequate tooth structure.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical and Radiographic Efficacy of Bioflx Crowns as Compared to Stainless Steel Crowns |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bioflx Crowns are biocompatible & non irritant to the Gingival tissue |
12 months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 2 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| 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="6"
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
|
With the continuous evolution of
pediatric prosthodontics, aesthetics has emerged as a primary focus. Beyond
anterior aesthetics, there is a growing demand for posterior aesthetics. To meet this demand, numerous
innovations are underway for posterior aesthetic crowns. Validating these
inventions requires dedicated research to compare them with existing
conventional crowns. As per the existing literature, the
stainless steel crowns have been compared with other tooth colored restorations
on the clinical parameters such as marginal integrity, crown retention,
proximal contact, gingival and periodontal response color stability. There is insufficient literature available regarding
TMJ dysfunction, occlusion, opposing tooth wear on both stainless steel as well
as Bioflx crowns. This emphasizes the importance of assessing
occlusion and potential temporomandibular joint (TMJ) dysfunctions over time. |