EVALUATION of PREVENTIVE EFFECT of SEALANTS and LASER THERAPY on DENTAL CARIES and POSTERUPTIVE BREAKDOWN on MOLARS AFFECTED with MOLAR INCISOR HYPOMINERALISATION (RANDOMIZED CLINICAL TRIAL)

Not Applicable

Recruiting

• Conditions: Molar Incisor Hypomineralization

• Registration Number: NCT06801561
• Lead Sponsor: Alexandria University

Brief Summary

Background: Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrical involvement of one to four permanent first molars (PFM) with or without incisor teeth involvement. MIH molars are prone to post-eruptive breakdown (PEB) and to the development of atypical caries lesions.

Aim of the study: To evaluate and compare the preventive effect of glass ionomer sealant and laser therapy (LT) against dental caries and PEB on molars affected by molar incisor hypomineralisation (MIH) Materials and Method: This study is a two-arm, parallel group, randomized clinical trial. A sample of children (n=134) with an age range of 6-9 years old, having a first permanent molar erupted with MIH without PEB or carious lesion, will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. All selected 134 first permanent molars will be randomly and equally allocated into two groups. Group 1(n=67): LT and Group 2 (n=67): Glass ionomer sealant (Fuji triage). Dental caries, PEB, retention of sealant and child-self-reported discomfort will be clinically evaluated after 6, 12 and 18months. Associations between dental caries and PEB with independent variables will be evaluated using logistic regression analysis (p \< 0.05).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-06
• Study First Submitted: 2025-01-25
• Study First Submitted QC: 2025-01-25
• Last Update Submitted: 2025-01-25
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• 6-9 years old children (29)
• One tooth with MIH with no PEB according to evaluation criteria proposed by Ghanim (2017) (APPENDIX I) (30) and ICDAS scores 0, 1 and 2 (APPENDIX II) (31)
• Good overall health (ASA I) (APPENDIX III) (32)

Exclusion Criteria

• First permanent molars with active carious lesions with ICDAS scores 5 and 6 (Appendix II) or defective restorations (31)
• Sufficient dentin loss that requires restorative therapy
• Any clinical signs of failure (abscess, fistula)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-eruptive breakdown / dental caries	21 months	Initially, two examiners (MB and GW) will be pre-trained and calibrated to perform the MIH diagnosis based on the criteria described by Ghanim (2017). and ICDAS

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt