Assessing Clinical Outcomes of Stainless Steel Crown and Bioflx Crowns in Primary Molars: a Prospective Study

RESEARCH DESIGN-

The split-mouth Randomization Controlled Trial will be conducted following Consolidated Standards of Reporting Trials (CONSORT) flow checklist.

A total of 55 Healthy children,aged between 4-7 years,were enrolled,contributing 55paired primary molars requiring crown placement .The study protocol will be thoroughly explained to all participant ,and written consent will be obtained from parents on behalf of their children.

RESEARCH SETTING

The present in-vivo study will be conducted in the Department of Pediatric Dentistry,Saraswati Dental College and Hospital,Lucknow after obtaining clearance from Institutional Ethical Committee.

STUDY POPULATION: Pediatric patients  aged 4-8years requiring full-coverage crowns on contra-lateral molars.

 INTERVENTION: Placement of Bioflx crown and Stainless-steel crown on contralateral sides in the same dental arch of each patient.

 **COMPARISON:**Newly introduced tooth colored Bioflx crown with conventional Stainless-Steel crown as full-coverage restoration in primary molars.

**Randomization:**Randomization will be performed using computerized software.

Allocation sequence generation: Each number from the randomization list will be written on a white paper and placed in an envelope by a third person not involved in the study. Allocation will occur only after the envelope is opened.

Allocation sequence concealment: Opaque envelopes, numbered consecutively, will be used to conceal the allocation. The envelopes will be opened by an assistant who will not be part of the research team.

Outcome assessment blinding: Blinding of the operator and participants will not be possible due to differences in the material and color of the crowns.

All clinical procedures in the trial will be performed by a single operator, who will be calibrated for crown selection, tooth preparation, and crown cementation. Evaluation will be conducted by one assessor, while data entry will be carried out by a third evaluator who will remain completely blinded.

 OUTCOME: Multiple clinical and patient-related factors such as:

 1) Time taken for   procedure.

2. Resistace to dislodgement.

3. Colour match.

4. Staining of crown.

5. Gingival  health.

6. Retention of crown.

7. Plaque retention.

8.  Occlusal wear of luted crown.

9. Secondary caries at crown margin.

10. Parental satisfaction.

 Assessed by using United States Public Health Services(USPHS) criteria ,for direct clinical evaluation.

For Gingival index : Loe and Silness scoring criteria  (1963)  will be used

both types of groups at baseline, 6 months and 12 months’ followup visit.

 Plaque index  will be determined by simplified Greene and Vermillion oral hygiene index.

 INCLUSION CRITERIA

1.Children aged between 4 to 8 years.

2.Primary Molars having large carious lesion involving multiple surfaces.

3.Endodontically treated Primary Molars.

4.Child with at least two Primary Molars contra-laterally.

5.Parents willing to provide written consent.

6.Frankl’s positive and definitely positive patients..

 EXCLUSION CRITERIA

1.Child with parafunctional habit.

2.Child with special needs.

3. Any known allergy to nickle.

4.Presence of Malocclusion such as crossbite or scissor bite.

5.Physiologic mobility of tooth/teeth near exfoliation period.

6.Severly decayed primary molar prohibiting retention and sealing of restoration.

**7.**children/parents not willing to participate in the study.