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临床试验/NCT06692257
NCT06692257已完成不适用

Orofacial Functions With Emphasis on Breathing and Chewing Patterns in Individuals With and Without Molar Incisor Hypomineralization: Observational Study Protocol

University of Nove de Julho1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年3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
已完成
入组人数
56
试验地点
1
主要终点
Assessment of orofacial function (NOT-S) - (score from 0 to 12)

研究概览

简要总结

Molar incisor hypomineralization (MIH) is a qualitative developmental defect of the enamel with a complex, multifactorial nature and a significant genetic component that predominantly affects the permanent first molars and, occasionally, the permanent incisors. Individuals with MIH may present a compromised stomatognathic system manifested by muscle hyperactivity under postural and dynamic conditions. However, there is a gap in knowledge regarding the specific functional abnormalities experienced by these individuals. The aim of this study was to perform a comparative analysis of orofacial functions, with emphasis on breathing and chewing patterns, in individuals with and without MIH. Assessments were performed using the Nordic Orofacial Test-Screening (NOT-S). Descriptive statistics were conducted, and comparisons were performed using the chi-square test, adopting a 5% significance level.

详细描述

This observational cross-sectional study was conducted to evaluate orofacial functions in children aged 6 to 12 years with and without molar incisor hypomineralization (MIH). Participants were recruited from the Pediatric Dentistry Clinic of Universidade Nove de Julho (UNINOVE), São Paulo, Brazil. MIH diagnosis was established according to the criteria proposed by Ghanim et al. Hypersensitivity was assessed using the Visual Analog Scale (VAS) and the Schiff Cold Air Sensitivity Scale (SCASS). Orofacial functions were evaluated using the Nordic Orofacial Test-Screening (NOT-S), which includes both interview and clinical examination components. The sample consisted of 56 children divided into two groups: with MIH (n=28) and without MIH (n=28). Data collection was conducted in a single clinical session. Statistical analysis included descriptive statistics, chi-square tests for categorical variables, and Wilcoxon tests for continuous variables, with a significance level set at 5%. Correlations were assessed using Spearman's correlation coefficient.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • •Children 6 to 12 years of age with a complete mixed dentition with all first molars present and in occlusion;
  • •Having all first molars erupted, without caries or previous treatment;
  • •Inclusion criteria for the MIH group: at least one permanent molar with indices compatible with MIH (code 2, 21, 22 and 3 - Ghanim criteria).

排除标准

  • •Children with amelogenesis and dentinogenesis imperfecta;
  • •Children undergoing orthodontic treatment;
  • •Children with a genetic syndrome;
  • •Children with the premature loss of deciduous teeth;
  • •Children with acute respiratory problems;
  • •Children in treatment.

研究组 & 干预措施

Individuals with MIH

At least one permanent molar with indices compatible with MIH (code 2, 21, 22 and 3 - Ghanim criteria)

干预措施: Observation (Behavioral)

Individuals without MIH

All permanent molars without indices compatible with MIH

干预措施: Observation (Behavioral)

结局指标

主要结局

Assessment of orofacial function (NOT-S) - (score from 0 to 12)

时间窗: Baseline

The following functions are addressed during the interview: (I) sensory function, (II) breathing, (III) habits, (IV) chewing and swallowing, (V) drooling and (VI) dryness of the mouth. The following functions are evaluated during the physical examination: (1) face at rest, (2) nose breathing, (3) facial expression, (4) masticatory muscle and jaw function, (5) oral motor function and (6) speech. For the evaluation of orofacial dysfunction during the clinical examination, the participants will be asked to perform tasks for each item in accordance with the illustrated manual. Each item has criteria for the respective function. A "YES" response or task the meets the criteria for compromised function will be scored 1 point, indicating dysfunction in the respective domain. A "NO" response or task that does not meet the criteria will be scored zero. The total is the sum of the points of all domains and ranges from 0 to 12, with higher scores denoting greater orofacial disfunction.

次要结局

  • Assessment of hypersensitivity in teeth with MIH: Visual analog scale (VAS)(Baseline)
  • Schiff cold air sensitivity scale (SCASS)(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Kalil Bussadori

Principal Investigator

University of Nove de Julho

研究点 (1)

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