Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Sealant retention
研究概览
简要总结
This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity.
详细描述
Molar Incisor Hypomineralization (MIH) poses a significant clinical challenge in pediatric dentistry due to enamel fragility, hypersensitivity, and increased susceptibility to caries. While conventional resin-based fissure sealant (RBFS) is the gold standard fissure sealant material for occlusal caries, its performance on hypomineralized enamel remains suboptimal. Bioactive sealants are newly developed materials that promote remineralization and utilize both mechanical and chemical adhesion; however, they demonstrate poor retention when used with their self-etching primer. Bioactive sealants with phosphoric acid pre-etching may offer improved clinical outcomes for MIH-affected teeth. This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity. Participants will be randomly allocated to receive either a bioactive sealant with phosphoric acid pre-etching or conventional RBFS. Clinical evaluations will be performed at 3-, 6-, and 12- months post-application using Modified United States Public Health Service (USPHS) criteria to assess retention, marginal adaptation, and secondary caries formation. Pre and postoperative sensitivity will be measured using the Schiff Cold Air Sensitivity Scale (SCASS).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6-12-year-old patients with at least one fully erupted first permanent molar (FPM) diagnosed with MIH defects (White, creamy, or yellow to brownish opacities greater than one millimetre) without posteruptive enamel breakdown or caries (ICDAS code 0 or 1).
- •Non -contributory medical history
- •Children must exhibit sufficient cooperation for treatment.
- •FPMs status of eruption must allow for proper isolation.
排除标准
- •Medically compromised patient.- Partially erupted MIH first permanent molars that could not be sufficiently isolated.
- •Carious molars.
- •Restored MIH molars.
- •Sealed MIH molars.
- •MIH molars with extensive enamel breakdown that requires restoration.
- •MIH molars planned for extraction (compensatory or balancing extraction) as part of elective extraction plan of MIH molars with poor long-term prognosis.
- •Molars affected with other enamel defects ((e.g., amelogenesis imperfecta or fluorosis)
- •Non-MIH affected molars.
- •Parents did not consent for treatment.
- •Child not sufficiently cooperative for treatment.
研究组 & 干预措施
Pre-etched Bioactive Sealant
Bioactive fissure sealant applied after etching with phosphoric acid
干预措施: Pre-etched Bioactive Sealant (Procedure)
Resin-based fissure sealant
Resin-based fissure sealant is applied after etching with phosphoric acid
干预措施: Conventional Resin-based Sealant (Procedure)
结局指标
主要结局
Sealant retention
时间窗: 3,6 and 12 months
Evaluation of sealant retention using the Modified United States Public Health Service (USPHS) criteria under good light source and using a dental mirror and a straight explorer
Marginal integrity
时间窗: 3,6 and 12 months
Evaluation for the presence of fractures or gaps in the sealant-tooth interface using the Modified United States Public Health Service (USPHS) criteria under a good light source and using a dental mirror and straight explorer.
Marginal discoloration
时间窗: 3,6 and 12 months
Evaluation for marginal discolouration using the Modified United States Public Health Service (USPHS) criteria under good light source and using a dental mirror
Secondary Caries
时间窗: 3,6 and 12 months
Evaluation for new caries using the Modified United States Public Health Service (USPHS) criteria under a good light source and using a dental mirror and a straight explorer.
Anatomic form
时间窗: 3,6 and 12 months
Evaluation of anatomic form using the modified United States of Public Health Service Criteria.
Surface Texture
时间窗: 3,6 and 12 months
Evaluation for surface texture using the modified United States of Public Health Service Criteria
次要结局
- Sensitivity(Pre-operative, 3,6, and 12 months)
