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临床试验/NCT07336212
NCT07336212
招募中
不适用

Impact of Restorative Treatment on Occlusal Characteristics and Masseter Muscle Activity in Children With Molar-Incisor Hypomineralization: A T-Scan and sEMG Pilot Study

Marmara University2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2026年1月10日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
5
试验地点
2
主要终点
Lateral Occlusal Force Distribution (LOFD)

概览

简要总结

This prospective pilot study evaluates the effect of restoring symptomatic, carious molar-incisor hypomineralization (MIH)-affected permanent molars using a glass-hybrid restorative material on occlusal force distribution and masticatory muscle activity. Digital occlusal analysis using the T-Scan system and surface electromyography (sEMG) recordings of the masseter and anterior temporalis muscles are performed before treatment and three months after restoration. Hypersensitivity is assessed using the Schiff Cold Air Sensitivity Scale.

详细描述

This single-arm prospective pilot study investigates whether restorative rehabilitation of MIH-affected permanent molars leads to functional improvements in occlusal balance and neuromuscular activity. Children aged 7-13 years with symptomatic MIH requiring restorative treatment undergo standardized glass-hybrid restorations. Functional occlusal analysis is conducted using the T-Scan Novus system to assess lateral occlusal force distribution, while bilateral surface electromyography (sEMG) evaluates masseter and temporalis muscle activity during maximum voluntary clenching. Dentin hypersensitivity is assessed using the Schiff Cold Air Sensitivity Scale. Pre- and post-treatment outcomes are compared to explore early functional adaptation following MIH rehabilitation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 7 to 13 years
  • Diagnosis of molar-incisor hypomineralization (MIH) according to the criteria of Ghanim et al.
  • Presence of at least two MIH-affected first permanent molars with post-eruptive enamel breakdown requiring restorative treatment
  • Presence of dentin hypersensitivity in the affected molars
  • Ability to comply with T-Scan and surface electromyography (sEMG) recording procedures
  • Written informed consent obtained from parents or legal guardians, and assent from the child

排除标准

  • Previous or ongoing orthodontic treatment
  • Presence of craniofacial anomalies or syndromes
  • Diagnosis of temporomandibular disorders
  • Parafunctional habits (e.g., bruxism)
  • Clinically evident facial asymmetry
  • Malocclusions such as crossbite or open bite
  • Systemic diseases or medications affecting neuromuscular function -Inability to cooperate with functional assessment procedures -

研究组 & 干预措施

Glass-Hybrid Restoration in MIH-Affected Molars

Experimental

Participants receive restorative treatment of symptomatic, carious first permanent molars affected by molar-incisor hypomineralization using a bulk-fill glass-hybrid restorative material (Equia Forte®). Functional assessments, including digital occlusal analysis with the T-Scan system and surface electromyography (sEMG) recordings of the masseter and anterior temporalis muscles, are performed at baseline and 3 months after restoration.

干预措施: Glass-Hybrid Restoration (Procedure)

结局指标

主要结局

Lateral Occlusal Force Distribution (LOFD)

时间窗: Baseline and 3 months post-treatment

Change in lateral occlusal force distribution assessed using the T-Scan digital occlusal analysis system during maximum voluntary clenching. The primary variable is the absolute deviation from ideal 50-50 bilateral force distribution, calculated at baseline and 3 months after glass-hybrid restoration.

次要结局

  • Masticatory Muscle Activity Symmetry(Baseline and 3 months post-treatment)
  • Dentin Hypersensitivity(Baseline and 3 months post-treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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