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)

NCT ID: NCT06801561

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-06-30

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).

Conditions

Molar Incisor Hypomineralization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test group

This group will be subjected to laser therapy. Er,Cr:YSGG will be used (Waterlase®, Biolase, USA) of a wavelength of 2780 nm at a power of 0.75 W using a frequency of 20 Hz and pulse duration of 140 µs. Irradiation will be performed on the entire occlusal and at the hypomineralized areas. The laser tip will pass in a uniform scanning motion steadily for 20 sec with relative isolation with 11% air and no water-cooling system. During the laser treatment, all safety measures will be followed.

Group Type: EXPERIMENTAL

Laser therapy

Intervention Type: PROCEDURE

This group will be subjected to laser therapy. Er,Cr:YSGG will be used (Waterlase®, Biolase, USA) of a wavelength of 2780 nm at a power of 0.75 W using a frequency of 20 Hz and pulse duration of 140 µs. (33) Irradiation will be performed on the entire occlusal and at the hypomineralized areas. (34) The laser tip will pass in a uniform scanning motion steadily for 20 sec with relative isolation with 11% air and no water-cooling system. During the laser treatment, all safety measures will be followed.

Control group

This group will receive glass ionomer sealant. Conditioning of the surface will be done using polyacrylic acid (10%) conditioner for 20 seconds, then rinsed and dried. Fuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs.

Group Type: ACTIVE_COMPARATOR

Glass ionomer sealant

Intervention Type: PROCEDURE

This group will receive glass ionomer sealant. Conditioning of the surface will be done using polyacrylic acid (10%) conditioner for 20 seconds, then rinsed and dried. Fuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs.

Interventions

Laser therapy

This group will be subjected to laser therapy. Er,Cr:YSGG will be used (Waterlase®, Biolase, USA) of a wavelength of 2780 nm at a power of 0.75 W using a frequency of 20 Hz and pulse duration of 140 µs. (33) Irradiation will be performed on the entire occlusal and at the hypomineralized areas. (34) The laser tip will pass in a uniform scanning motion steadily for 20 sec with relative isolation with 11% air and no water-cooling system. During the laser treatment, all safety measures will be followed.

Intervention Type: PROCEDURE

Glass ionomer sealant

This group will receive glass ionomer sealant. Conditioning of the surface will be done using polyacrylic acid (10%) conditioner for 20 seconds, then rinsed and dried. Fuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs.

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Baraka

Lecturer, Pediatric dentistry department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alexandria University

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Marwa Baraka

Role: CONTACT

marwa.baraka87@gmail.com

+20 10 00804757

Rodaina H Helmy

Role: CONTACT

rodainahhelmy@gmail.com

01100001193

Facility Contacts

Alexandria University

Role: primary

Other Identifiers

AlexU-MB-MIH

Identifier Type: -

Identifier Source: org_study_id