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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Post-eruptive breakdown
研究概览
简要总结
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%).
详细描述
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%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: GIC sealant (GC Fuji TRIAGE®) (Procedure)
Control
Children allocated to this group will receive the same dietary advices and brushing instructions described in the control arm.
干预措施: Control (Procedure)
结局指标
主要结局
Post-eruptive breakdown
时间窗: After 12 months
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
次要结局
- 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.)
研究者
Isabel Cristina Olegário da Costa
PhD
University of Sao Paulo