Evaluating sealants and laser therapy for preventing dental issues in children with molar incisor hypomineralisation
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)
This study is testing whether using special sealants or laser therapy can help prevent dental problems in children aged 6-9 who have weak spots on their molars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 6 Years to 9 Years |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT06801561 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of glass ionomer sealants and laser therapy in preventing dental caries and post-eruptive breakdown in children aged 6-9 years with molar incisor hypomineralisation. The study will involve 134 children who have at least one first permanent molar affected by MIH but without any carious lesions or post-eruptive breakdown. Participants will be randomly assigned to receive either the sealant or laser therapy, and their dental health will be monitored over time to evaluate the outcomes of these interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children aged 6-9 years with at least one first permanent molar affected by molar incisor hypomineralisation without any carious lesions.
Not a fit: Patients with active carious lesions or significant dentin loss requiring restorative therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective preventive measures for dental caries and breakdown in children with molar incisor hypomineralisation.
How similar studies have performed: While there is limited data on the specific combination of sealants and laser therapy for MIH, similar preventive approaches have shown promise in managing dental caries in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Alexandria
- Alexandria University — Alexandria, Egypt (Recruiting)
Study contacts
- Study coordinator: Marwa Baraka
- Email: marwa.baraka87@gmail.com
- Phone: +20 10 00804757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.