| CTRI Number |
CTRI/2025/06/089906 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study to Compare Three Types of Dental Crowns in Children with Damaged Permanent molar. |
|
Scientific Title of Study
|
Comparative Assessment of Bioflx crown, Composite crown and Stainless steel crown in patient having Molar incisor hypomineralisation: A Randomised Clinical 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 Anshula Deshpande |
| Designation |
Professor |
| Affiliation |
K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University |
| Address |
Dept. of Pediatric and Preventive Dentistry,K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University,Piparia,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7600916400 |
| Fax |
|
| Email |
dranshula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshula Deshpande |
| Designation |
Professor |
| Affiliation |
K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University |
| Address |
Dept. of Pediatric and Preventive Dentistry,K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University,Piparia,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7600916400 |
| Fax |
|
| Email |
dranshula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshula Deshpande |
| Designation |
Professor |
| Affiliation |
K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University |
| Address |
Dept. of Pediatric and Preventive Dentistry,K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University,Piparia,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7600916400 |
| Fax |
|
| Email |
dranshula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry,K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University, Vadodara,391760,Gujarat,India |
|
|
Primary Sponsor
|
| Name |
Dr Anshula Deshpande |
| Address |
Department of Pediatric and Preventive Dentistry,K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University, Vadodara,391760,Gujarat,India |
| 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 Anshula Deshpande |
K.M Shah Dental college & Hospital |
No. 3,Department of Pediatric and Preventive Dentistry,K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University, Vadodara,391760,Gujarat,India
Vadodara
GUJARAT |
7600916400
dranshula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SVIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K004||Disturbances in tooth formation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Bioflx crown (Kids-e-dental) cemented with GIC
Group B: Composite crown (Pedocrown) cemented with flowable composite resin
|
Group A- Preformed Bioflx crown (Bioflx, Kids-e-dental) used for restoring MIH-affected permanent molars. Tooth is minimally prepared using tapered diamond bur. Crown is contoured using How pliers and cemented with Type I Glass Ionomer Cement (GC Fuji, Japan). Duration of study is 24 months.
Group B - Preformed composite resin crown (PedoCrown) placed on permanent molars with MIH. Tooth is prepared using straight fissure and 169L burs. Trial fit is checked before final cementation with flowable composite (3M ESPE Z350).Duration of study is 24 months.
|
| Comparator Agent |
Group C: Stainless Steel Crown (3M ESPE) cemented with GIC |
Preformed metal crown (3M ESPE, United States) placed on permanent molars affected by MIH. Tooth is prepared using tapered and 169L burs, followed by trial fitting. Crown is contoured and crimped, then cemented using Type I Glass Ionomer Cement (GC Fuji, Japan). Excess cement is cleaned and occlusion verified. Duration of study is 24 months. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between 7 to 14 years having permanent molars diagnosed with MIH-TNI20 score 2 (MIH with enamel breakdown but without hypersensitivity) & Score 4 (MIH with enamel breakdown and with hypersensitivity)
2. Normal and healthy Co-operative participants.
3. Parents/Guardian who are willing to give a written informed consent and assent by participants will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1. A pathological discrepancy of root resorption
2. Inflammation at the furcation area
3. Permanent teeth having not sufficient crown structure
4. Teeth with root caries
5. Mentally challenged or disabled childrens and children with any type of dentofacial abnormality will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical performance of crowns using the Modified United States Public Health Service (USPHS) Criteria |
baseline, 6 months, 12 months, 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare the satisfaction levels of parents and children regarding Stainless Steel Crowns, Composite Crowns, and Bioflx Crowns placed on permanent molars affected by MIH.
Parameters Assessed:
Satisfaction will be measured using a structured questionnaire based on a 5-point Likert scale covering:
1. Crown color
2. Crown size and shape
3. Overall appearance
4. Comfort and acceptability (child-specific)
5. General satisfaction with treatment (parent-specific)
|
12 months
24 months |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
14/07/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a randomized clinical trial designed to
compare the clinical performance and patient satisfaction of three different
types of dental crowns—Stainless Steel Crown (SSC), Composite Crown, and Bioflx
Crown—in children aged 7 to 14 years with Molar-Incisor Hypomineralisation
(MIH). A total of 57 teeth will be randomly assigned into three groups.
Clinical success will be evaluated using Modified United States Public Health
Service (USPHS) criteria, and satisfaction will be assessed through structured
questionnaires for parents and children using a 5-point Likert scale. Follow-up
evaluations will be conducted at 6, 12, and 24 months post-treatment to
determine which crown provides the best outcome in terms of durability,
functionality, and esthetics.
|