| CTRI Number |
CTRI/2025/07/090381 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Clinical and radiographic evaluation of two types of crowns used in milk teeth. |
|
Scientific Title of Study
|
Comparative evaluation of clinical and radiographic success of bioflx crowns and stainless steel crowns in primary molars: 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 N Sushanth Billava |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and research institute, Bangalore |
| Address |
Room no 5 Department of pedodontics Government dental college and research institute, Victoria campus, Kalasipalya, near city market, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
8105530829 |
| Fax |
|
| Email |
billavasushanth9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mallayya C Hiremath |
| Designation |
Associate professor |
| Affiliation |
Government dental college and research institute, Bangalore |
| Address |
Room no 5 Department of pedodontics Government dental college and research institute, Victoria campus, Kalasipalya, near city market, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9686793102 |
| Fax |
|
| Email |
drmallayyahiremath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mallayya C Hiremath |
| Designation |
Associate professor |
| Affiliation |
Government dental college and research institute, Bangalore |
| Address |
Room no 5 Department of pedodontics Government dental college and research institute, Victoria campus, Kalasipalya, near city market, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9686793102 |
| Fax |
|
| Email |
drmallayyahiremath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and research institute, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr N Sushanth Billava |
| Address |
Government dental college and research institute, Bangalore |
| 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 N Sushanth Billava |
Government dental college and research institute, Bangalore |
Department of pediatric and preventive dentistry, Government dental college and research institute, Bangalore, 560002
Bangalore
KARNATAKA |
8105530829
billavasushanth9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GOVERMENT DENTAL COLLEGE AND RESEARCH INSTITUITE BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy co-operative participants in the age group of 6-9 years who have received pulp therapy
or with multi surface carious lesions of primary molars, bilaterally. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioflx crown on primary molars treated with pulp therapy or with multi-surface carious lesions |
1 year 6 months |
| Comparator Agent |
stainless steel crown on primary molars treated with pulp therapy or with multi-surface carious lesions |
1 year 6 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1)Systemically healthy, co–operative participants (Frankl’s positive and definitely positive) aged 6 to 9 years with primary molars treated with pulp therapy (IPC, Pulpotomy, Pulpectomy) or with multi-surface carious lesions bilaterally.
2)Restorable primary molars functioning in occlusion with an opposing tooth, and possessing at least one contact area with an adjacent tooth |
|
| ExclusionCriteria |
| Details |
1)Inappropriately obturated primary molars.
2)Tooth with internal resorption or tooth with more than one third of root resorption.
3)Patients with very poor oral hygiene and DMFT or dmft score greater than 5.
4)Patients with known allergy to local anesthesia, chromium, nickel and resin material.
5)Patients with bruxism and other parafunctional habits. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of clinical success and radiographic success of Bioflx crowns and stainless steel crowns.
|
12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque scores and gingival health around the Bioflx crowns and stainless steel
crowns. |
12 months. |
| Patient and parental satisfaction with Bioflx crowns and Stainless steel crowns. |
12 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2025 |
| 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
|
NEED FOR STUDY Dental caries in children is a serious public health issue. It is now equally important to do different
restorative procedures on the deciduous dentition in order to preserve their function and aesthetics. Due
to rising awareness aesthetics is becoming more and more important in pediatric dentistry these days.
There is a driving demand for quick, minimally invasive, and aesthetic restorations in pediatric
dentistry. For full coverage restorations, stainless steel crowns continue to be the gold standard even after being
introduced decades back. Their strength, retention, and conservative tooth preparation are the benefits,
however their primary drawback being unesthetic. Zirconia crowns are thought to be the most
aesthetically pleasing choice for treating primary molars. These crowns have a high level of polish and
are tooth-coloured. The drawbacks of these crowns are their high cost, considerable dental preparation,
and inability to be altered and they abrade the opposing tooth. The first flexible, long- lasting, and
aesthetically pleasing prefabricated crown for primary molars is the Bioflx Crown, which is
manufactured by Kids-e-Dental since 2021. The medical device industry uses Bioflx materials. Bioflx
crowns are tooth coloured, monochromatic, metal-free, and composed of a high-strength resin polymer
that is highly durable, flexible, and strong. These crowns can be autoclaved and tooth preparation is
similar to stainless steel crowns. Thus, there is a need to assess clinically the gingival health and oral hygiene condition of teeth restored
with Bioflx crowns and stainless steel crowns. Keeping in mind the paucity of studies, this study aims
to evaluate the clinical and radiographic success and patient/parental satisfaction with Bioflx crowns
in comparison to stainless steel crowns in primary molars. |