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A Study to Compare Three Types of Dental Crowns in Children with Damaged Permanent molar.

Comparative Assessment of Bioflx crown, Composite crown and Stainless steel crown in patient having Molar incisor hypomineralisation: A Randomised Clinical Study. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089906
Enrollment
57
Registered
2025-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K004- Disturbances in tooth formation

Interventions

Intervention1: 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-de

Sponsors

Dr Anshula Deshpande
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Clinical performance of crowns using the Modified United States Public Health Service (USPHS) CriteriaTimepoint: baseline, 6 months, 12 months, 24 months

Secondary

MeasureTime frame
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) Timepoint: 12 months 24 months

Countries

India

Contacts

Public ContactDr Anshula Deshpande

K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University

dranshula@gmail.com7600916400

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026