NCT03870958

Glass Ionomer Cement Sealant in the Prevention of Post-eruptive Fractures in Molars Affected by MIH

Cost-effectiveness of the Application of Glass Ionomer Cement Sealant (GC Fuji TRIAGE®) in the Prevention of Post-eruptive Fractures in Molars Affected by Molar-Incisor Hipomineralisation: Controlled and Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: Isabel Cristina Olegário da Costa · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

This trial will compare the application of Glass Ionomer Cement (GIC) sealant with no-intervention for the most clinically- and cost-effective strategy for managing MIH molars without post-eruptive breakdown, in a school setting, using low-technology and child-friendly dental techniques. Methods/Design: This two-arm, parallel group, patient-randomized controlled, superiority trial will have treatment provided in schools. Schoolchildren (age 6-9), presenting at least one MIH molar (n molars = 195,) will have random allocation to treatment with or without the application of a GIC sealant (GC Fuji TRIAGE®, GC Europe, Leuven, Belgium). Baseline measures and outcome data will be assessed through participant report and clinical examination. The primary outcome is the presence of post-eruptive fracture and development of caries lesions. Secondary outcomes are: (1) self-reported dental hypersensitivity; (2) oral health-related-quality of life, reported by children; (3) plaque index, (4) gingival health, (5) caries status (according to ICCMS scores) in primary and permanent teeth; (6) the incremental cost-effectiveness. A trained and calibrated examiner will evaluate the treated teeth every six months post treatment for a period of 36 months. Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome. The Logistic Regression and Poisson Regression Analysis will be used to analyze the secondary outcomes (α=5%).

Detailed description

Background: Molar-Incisor Hypomineralisation (MIH) is defined as a qualitative defect that occurs during the mineralization phase of enamel of at least one first permanent molar. The opacities vary in size and color and are demarcated by healthy enamel. MIH molars present lower mechanical properties when compared to non-affected molars, due to the enamel's decreased mineralization. Allied to that, patients often report dental hypersensitivity, which impairs the mechanical removal of dental plaque; therefore, those molars are more prone to post-eruptive fractures and present higher risk of developing dental caries. This trial will compare the application of Glass Ionomer Cement (GIC) sealant with no-intervention for the most clinically- and cost-effective strategy for managing MIH molars without post-eruptive breakdown, in a school setting, using low-technology and child-friendly dental techniques. Methods/Design: This two-arm, parallel group, patient-randomized controlled, superiority trial will have treatment provided in schools. Schoolchildren (age 6-9), presenting at least one MIH molar (n molars = 195,) will have random allocation to treatment with or without the application of a GIC sealant (GC Fuji TRIAGE®, GC Europe, Leuven, Belgium). Baseline measures and outcome data will be assessed through participant report and clinical examination. The primary outcome is the presence of post-eruptive fracture and development of caries lesions. Secondary outcomes are: (1) self-reported dental hypersensitivity; (2) oral health-related-quality of life, reported by children; (3) plaque index, (4) gingival health, (5) caries status (according to ICCMS scores) in primary and permanent teeth; (6) the incremental cost-effectiveness. A trained and calibrated examiner will evaluate the treated teeth every six months post treatment for a period of 36 months. Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome. The Logistic Regression and Poisson Regression Analysis will be used to analyze the secondary outcomes (α=5%).

Conditions

• Molar Incisor Hypomineralization

Interventions

Type	Name	Description
PROCEDURE	GIC sealant (GC Fuji TRIAGE®)	Children allocated to this group will receive the same dietary advices and brushing instructions. Additionally, all MIH molars from will receive a GIC sealant (GC Fuji TRIAGE®, GC Europe, Leuven, Belgium).
PROCEDURE	Control	Children allocated to this group will receive the same dietary advices and brushing instructions.

Timeline

• Start date: 2018-11-20
• Primary completion: 2019-12-20
• Completion: 2021-12-20
• First posted: 2019-03-12
• Last updated: 2020-09-16

Locations

1 site across 1 country: Mexico