| CTRI Number |
CTRI/2024/06/068496 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two systems of full coronal restoration for primary molars |
|
Scientific Title of Study
|
Clinical evaluation and parental satisfaction of stainless steel crown versus bioflx crown in primary molars-an invivo study |
| 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 Shweta Kumar |
| Designation |
PG Student |
| Affiliation |
SGT University,Gurugram Haryana |
| Address |
Room no. 202, Department Of Pediatric And Preventive Dentistry,Faculty Of Dental Sciences,SGT University, Budhera, Gurugram ,Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9717740333 |
| Fax |
|
| Email |
drshwetachaudhary5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalu Verma |
| Designation |
Professor |
| Affiliation |
SGT University,Gurugram Haryana |
| Address |
Room no. 202, Department Of Pediatric And Preventive Dentistry,Faculty Of Dental Sciences,SGT University, Budhera, Gurugram ,Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9871720820 |
| Fax |
|
| Email |
drshalubhardwaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Kumar |
| Designation |
PG Student |
| Affiliation |
SGT University,Gurugram Haryana |
| Address |
Room no. 202, Department Of Pediatric And Preventive Dentistry,Faculty Of Dental Sciences,SGT University, Budhera, Gurugram ,Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9717740333 |
| Fax |
|
| Email |
drshwetachaudhary5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty Of Dental Sciences, SGT University |
|
|
Primary Sponsor
|
| Name |
Faculty Of Dental Sciences SGT University |
| Address |
Room no. 202, Department Of Pediatric And Preventive Dentistry,Faculty Of Dental Sciences,SGT University, Budhera, Gurugram ,Haryana 122505 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SHWETA KUMAR |
FACULTY OF DENTAL SCIENCES,SGT UNIVERSITY |
Room no. 202, Department Of Pediatric And Preventive Dentistry,Faculty Of Dental Sciences,SGT University, Budhera, Gurugram ,Haryana 122505
Gurgaon
HARYANA |
09717740333
drshwetachaudhary5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee-Sgt Dental College, Hospital And Research Institute (Iec-Sgtdchri) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dental problems |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIOFLX Crowns |
These are tooth coloured crowns with better flexibility providing better contour and fit which is clinically seen at 3,6 and 9 months . |
| Comparator Agent |
Stainless Steel Crowns |
To compare clinical success of two systems of full coronal restorations for primary molar teeth with a follow up at 3, 6 and 9 months. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
children aged 4-9 who are healthy and free of any systemic disease.carious primary molar teeth involving two or more surfaces and fulfilling criteria for full coronal restoration. |
|
| ExclusionCriteria |
| Details |
any tooth nearing exfoliation or not fit for full coronal restoration. any radiographic evidence of periapical pathology, children with systemic health problem ,periodontal disease or allergies to local anesthesia or nickel |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical evaluation and parental satisfaction of stainless steel crown versus bioflx crowns in primary molars -an invivo study |
clinical evaluation at baseline ,three ,six and nine months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical performance of stainless steel crowns when used for primary molars, to evaluate the clinical performance of bioflx crowns when used for primary molars,to compare the clinical performance of stainless steel crowns and bioflx crowns when used for primary molars |
clinical evaluation at baseline ,three ,six and nine months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
06/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Dental crowns in pediatric dentistry play a crucial role not only in the restoration of the decayed and damaged tooth but also in the overall health and psychological well-being of children. SSC crown has always been the gold standard crown in pediatric dentistry but its metallic appearance is frequently raised as an issue by children and parents. In the recent years with technological advancement in dental materials various approaches for full coverage restoration has emerged in pediatric dentistry. Recently a highly aesthetic BIOFLX crowns are introduced in pediatric dentistry. However, there is lack of comprehensive studies assessing the properties of BIOFLX crowns, their impact on clinical outcomes and parental satisfaction. So, this study will compare the clinical performance of stainless steel crowns and bioflx crowns when used for primary molars. |