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)

NCT06801561 | Recruiting

• 1 other identifier: AlexU-MB-MIH
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Keywords

Molar Incisor Hypomineralisation; laser; sealant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Laser therapy 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.

Test group

Glass ionomer sealant 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.

Control group

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Marwa Baraka

CONTACT

+20 10 00804757; marwa.baraka87@gmail.com

Rodaina H Helmy

CONTACT

01100001193; rodainahhelmy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Pediatric dentistry department

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: January 30, 2025
• Study Start: March 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 30, 2025

Record last verified: 2024-06

Locations

EG (1)