| CTRI Number |
CTRI/2024/03/064787 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Advancements in pediatric posterior crowns. |
|
Scientific Title of Study
|
Evaluation of preformed BioFlx crowns, Zirconia crowns and Stainless-steel crowns on primary molars: A 12-month 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 Nidhi S Shetty |
| Designation |
Post Graduate Student |
| Affiliation |
RajaRajeswari Dental College and Hospital |
| Address |
Dept of Paediatrics and Preventive Dentistry
No 14 Ramohalli Cross Mysore Road
Kumbalgodu Bengaluru
Bangalore KARNATAKA 560074 India |
| Phone |
9740636863 |
| Fax |
|
| Email |
nidhishetty2099@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amrutha Ujjamma B |
| Designation |
Reader |
| Affiliation |
RajaRajeswari Dental College and Hospital |
| Address |
RajaRajeswari Dental College and Hospital
No 14 Ramohalli Cross Mysore Road
Kumbalgodu Bengaluru
Bangalore KARNATAKA 560074 India |
| Phone |
8105700221 |
| Fax |
|
| Email |
amrutha.b87@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nidhi S Shetty |
| Designation |
Post Graduate Student |
| Affiliation |
RajaRajeswari Dental College and Hospital |
| Address |
Dept of Paediatrics and Preventive Dentistry
No 14 Ramohalli Cross Mysore Road
Kumbalgodu Bengaluru
Bangalore KARNATAKA 560074 India |
| Phone |
9740636863 |
| Fax |
|
| Email |
nidhishetty2099@gmail.com |
|
|
Source of Monetary or Material Support
|
| RajaRajeswari Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr. Nidhi S Shetty |
| Address |
RajaRajeswari Dental College and Hospital
Dept of Pediatric and Preventive Dentistry
No 14 Ramohalli Cross Mysore Road
Kumbalgodu Bengaluru 560074 |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 Nidhi S Shetty |
RajaRajeswari Dental College and Hospital |
Dept of Pediatric and Preventive Dentistry
No 14 Ramohalli Cross Mysore Road
Kumbalgodu Bengaluru Bangalore KARNATAKA |
9740636863
nidhishetty2099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RajaRajeswari Dental College and Hospital |
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 |
| Comparator Agent |
Modified USPHS criteria |
Total time required for preparation, fitting and cementation; plaque accumulation; retention of crown; tooth wear in opposing teeth; radiographic findings at baseline, 3months, 6 months and 12 months interval. |
| Intervention |
Posterior crown |
Stainless-steel crown, Zirconia crown, BioFlx crown for 1 year |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children of 3-9 years of age
Children healthy and free of any systemic diseases
Primary teeth requiring full coronal restorations following pulpotomy/pulpectomy
Primary teeth with at least 2/3rd of the root length remaining
Children who are co-operative (Frankl rating of 3 and 4)
Children for whom consent was obtained from parents |
|
| ExclusionCriteria |
| Details |
Teeth with tooth resorption.
Infection/ inflammation involving the furcation area.
Teeth with inadequate crown structure.
Children with any underlying diseases.
Children who are non-co-operative (Frankl rating of 1 and 2)
Parents who are not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the clinical outcome of preformed BioFlx crowns, Zirconia crowns and Stainless-Steel crowns over a period of 0, 3, 6 and 12 months when used to restore primary molars. |
The crown will be clinically assessed for: the total time required for preparation, fitting and cementation; plaque accumulation; retention of the crown; tooth wear in opposing teeth; and radiographic findings at baseline, 3 months, 6 months and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the child and parental satisfaction of preformed BioFlx crowns, Zirconia crowns and Stainless-Steel crowns. |
A questionnaire will be asked to fill at the end of 12 months |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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)
|
05/04/2024 |
| 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="2" Months="1" 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 present study will be done on children aged 3-9 years with extensive dental caries requiring full coverage restorations. A thorough clinical examination will be done for active dental caries using a plain dental mirror and explorer on the dental chair with optimal light, after which 45 primary teeth requiring crowns will be distributed randomly into three groups consisting of 15 participants in each: Group 1: Preformed Stainless-Steel crowns; Group 2: Preformed Zirconia crowns; Group 3: Preformed BioFlx crowns. Informed consent will be obtained from parents or guardians of children participating in this study. Patients having extensive dental caries who require full coverage restoration will then be shortlisted, who will undergo either pulpotomy or pulpectomy procedure after which they will be randomly distributed into the above mentioned three groups for crown placement. The operator would be blinded to the type of the crown until the beginning of tooth preparation. All the crowns will be clinically assessed by a single evaluator immediately after crown placement, at three months, six months and twelve months follow-up using United States Public Health Service (USPHS) criteria. The crown will be assessed for: the total time required for preparation, fitting and cementation; plaque accumulation; retention of the crown; tooth wear in opposing teeth; and radiographic findings. The outcome assessor will be blinded at the data entry level to avoid bias. Also, at 12 months the parents will be asked to complete a simple six-item Likert scale questionnaire to evaluate their satisfaction with the procedure. |