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)

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).

Study Overview

• Status: Recruiting
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Procedure: Laser therapy; Procedure: Glass ionomer sealant

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa Baraka; Phone Number: +20 10 00804757; Email: marwa.baraka87@gmail.com
• Study Contact Backup: Name: Rodaina H Helmy; Phone Number: 01100001193; Email: rodainahhelmy@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University
    • Contact: Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-eruptive breakdown / dental caries	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	21 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 25, 2025
• First Submitted That Met QC Criteria: January 25, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 25, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: laser; sealant; Molar Incisor Hypomineralisation
• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Demineralization; Tooth Abnormalities; Molar Hypomineralization; Dental Caries; Dental Enamel Hypoplasia
• Other Study ID Numbers: AlexU-MB-MIH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No