NCT03870958: MIHMex

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

Status unknown NA Last updated 16 September 2020

What this trial tests

NA trial testing GIC sealant (GC Fuji TRIAGE®) in Molar Incisor Hypomineralization in 195 participants. Status unknown.

Timeline

20 November 2018

Primary endpoint
20 December 2019

20 December 2021

Quick facts

Lead sponsor	Isabel Cristina Olegário da Costa
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	195
Start date	20 November 2018
Primary completion	20 December 2019
Estimated completion	20 December 2021
Sites	1 location across Mexico

Drugs / interventions tested

• GIC sealant (GC Fuji TRIAGE®)
• Control

Conditions studied

• Molar Incisor Hypomineralization — all drugs for Molar Incisor Hypomineralization →

Sponsor

Isabel Cristina Olegário da Costa

Who can join

Adults 6 to 9, any sex, with Molar Incisor Hypomineralization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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%).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glass Ionomer Sealants Can Prevent Dental Caries but Cannot Prevent Posteruptive Breakdown on Molars Affected by Molar Incisor Hypomineralization: One-Year Results of a Randomized Clinical Trial.
   Schraverus MS, Olegário IC, Bonifácio CC, González APR, et al · · 2021 · cited 13× · PMID 34107492 · DOI 10.1159/000516266
2. Outcome and comparator choice in molar incisor hypomineralisation (MIH) intervention studies: a systematic review and social network analysis.
   Elhennawy K, Krois J, Jost-Brinkmann PG, Schwendicke F. · · 2019 · cited 7× · PMID 31377700 · DOI 10.1136/bmjopen-2018-028352