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

NCT03870958 | Unknown

• 1 other identifier: MIHMex
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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%).

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (1)

• Post-eruptive breakdown

  A "success" will be accounted in cases when the no post-eruptive breakdown is detected, while a "failure" will be considered when a post-eruptive breakdown, atypical restoration, atypical caries or tooth missing due to MIH is perceived. Method: clinical evaluation by a calibrated examiner

  After 12 months

Secondary Outcomes (5)

• Caries lesions assessment

  Every 6 months up to 36 months

• Sealant retention

  Every 12 months up to 36 months

• Oral health-related quality of life (OHRQoL)

  Baseline and every 12 months up to 36 months

• Cost-efficacy of treatments

  Baseline, after treatment and every 12 months up to 36 months

• Hypersensitivity

  hypersensitivity will be evaluated at 6-month intervals so that evaluations will be completed in 6, 12, 18, 24, 30 and 36 months by the same examiner.

Study Arms (2)

GIC sealant (GC Fuji TRIAGE®)

EXPERIMENTAL

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: GIC sealant (GC Fuji TRIAGE®)

Control

ACTIVE COMPARATOR

Children allocated to this group will receive the same dietary advices and brushing instructions described in the control arm.

Procedure: Control

Interventions

GIC sealant (GC Fuji TRIAGE®) PROCEDURE

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).

GIC sealant (GC Fuji TRIAGE®)

Control PROCEDURE

Children allocated to this group will receive the same dietary advices and brushing instructions.

Control

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children whose parents or legal guardians accept and sign the informed consent form; -children who assent to participate into the research;
• aged between 6 and 9 years;
• exhibiting good general health conditions and cooperative behavior;
• presenting at least one MIH molar.

You may not qualify if:

• children presenting health conditions that impair the dental treatment, or children undergoing orthodontic treatment;
• MIH molars that present opacities not located on the occlusal surface, with post-eruptive breakdown, with the occlusal surface totally or partial covered by a gingival operculum, with caries dentine lesion (ICCMS score C), restorations or sealants.

Sponsors & Collaborators

• Isabel Cristina Olegário da Costa: lead
• University of Guadalajara: collaborator
• University of Dublin, Trinity College: collaborator
• Academic Centre for Dentistry in Amsterdam: collaborator

Study Sites (1)

Isaac Murisi Pedroza

Guadalajara, Jalisco, 47620, Mexico

Location

Related Publications (6)

• Ghanim A, Marino R, Manton DJ. Validity and reproducibility testing of the Molar Incisor Hypomineralisation (MIH) Index. Int J Paediatr Dent. 2019 Jan;29(1):6-13. doi: 10.1111/ipd.12433. Epub 2018 Oct 22.

  PMID: 30350324 BACKGROUND

• Folayan MO, Chukwumah NM, Popoola BO, Temilola DO, Onyejaka NK, Oyedele TA, Lawal FB. Developmental defects of the enamel and its impact on the oral health quality of life of children resident in Southwest Nigeria. BMC Oral Health. 2018 Sep 27;18(1):160. doi: 10.1186/s12903-018-0622-3.

  PMID: 30261858 BACKGROUND

• Ebel M, Bekes K, Klode C, Hirsch C. The severity and degree of hypomineralisation in teeth and its influence on oral hygiene and caries prevalence in children. Int J Paediatr Dent. 2018 Nov;28(6):648-657. doi: 10.1111/ipd.12425. Epub 2018 Sep 23.

  PMID: 30246468 BACKGROUND

• Velandia LM, Alvarez LV, Mejia LP, Rodriguez MJ. Oral health-related quality of life in Colombian children with Molar-Incisor Hypomineralization. Acta Odontol Latinoam. 2018 Jun;31(1):38-44.

  PMID: 30056465 BACKGROUND

• Fragelli CMB, Souza JF, Bussaneli DG, Jeremias F, Santos-Pinto LD, Cordeiro RCL. Survival of sealants in molars affected by molar-incisor hypomineralization: 18-month follow-up. Braz Oral Res. 2017 Apr 27;31:e30. doi: 10.1590/1807-3107BOR-2017.vol31.0030.

  PMID: 28489117 BACKGROUND

• Schraverus MS, Olegario IC, Bonifacio CC, Gonzalez APR, Pedroza M, Hesse D. 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. Caries Res. 2021;55(4):301-309. doi: 10.1159/000516266. Epub 2021 Jun 9.

  PMID: 34107492 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization

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

Study Officials

• Daniela Hesse, Professor

  Academic Centre for Dentistry in Amsterdam

  STUDY CHAIR

• Isaac M Pedroza Uribe, MSc

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: 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).

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: March 12, 2019
• Study Start: November 20, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)