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临床试验/NCT07504614
NCT07504614Enrolling By Invitation不适用

Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH): A Randomized Clinical Trial

Jordan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

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

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

Experimental

Bioactive fissure sealant applied after etching with phosphoric acid

干预措施: Pre-etched Bioactive Sealant (Procedure)

Resin-based fissure sealant

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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