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

Study Overview
=================
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%).

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%).

Official Title
-----------------
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

Conditions
-----------------
Molar Incisor Hypomineralization

Intervention / Treatment
-----------------
* Procedure: GIC sealant (GC Fuji TRIAGE®)
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 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. Exclusion criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GIC sealant (GC Fuji TRIAGE®)<br>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®)<br>* 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).<br>|
| Active Comparator: Control<br>Children allocated to this group will receive the same dietary advices and brushing instructions described in the control arm. | Procedure: Control<br>* Children allocated to this group will receive the same dietary advices and brushing instructions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries lesions assessment | The dental caries index ICCMS (Ismail et al., 2015) will be used. For that, a visual-tactile exam will be performed with the aid of an OMS probe. Method: clinical evaluation by a calibrated examiner | Every 6 months up to 36 months | 
| Sealant retention | The sealants 'retention will be clinically evaluated and scored as: 0- fully retained sealant; 1- partially retained sealant and 2- sealant absent (Oba et al., 2009). (Hilgert LA et al., 2017) Method: clinical evaluation by a calibrated examiner | Every 12 months up to 36 months | 
| Oral health-related quality of life (OHRQoL) | All children will be interviewed concerning their OHQoL by a local dentist. For that, the Child Perceptions Questionnaire (CPQ) will be used. This questionnaire has already been adapted and validated into Spanish-language (Carmen Aguilar-Díaz F et al., 2011). | Baseline and every 12 months up to 36 months | 
| Cost-efficacy of treatments | The cost-effectiveness analysis will take into account the direct and indirect costs of the procedures. The time spent in each session will be considered, with the total time spent timed by an external assistant. The numbers of consultations attended to each participant and the procedures performed will be registered. | Baseline, after treatment and every 12 months up to 36 months | 
| Hypersensitivity | A questionnaire will be used which will be applied to children with specific questions, a) presence of hypersensitivity when ingesting hot and cold drinks; b) hypersensitivity when brushing teeth. Clinically it will be used the methodology used by Mehta D, et al., 2015. A cold air stimulus (2-s air blast, approximately 40 psi, from a dental syringe directed perpendicular to the molar surface at 0.5 cm distance). Neighboring teeth were shielded with cotton rolls or with the fingers of the examiner. Immediately after stimulation patients were asked to point to the g visual analog scale VAS scale (no pain = 0 and worst pain = 10 cm) to the nearest full centimeter number describing their pain perception. Brushing the child's teeth will identify if the child has hypersensitivity and the VAS is used in the same way. | 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. |