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NCT Number: NCT06692257

Orofacial Functions in Individuals With and Without Molar Incisor Hypomineralization

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.

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Key information

Conditions

Molar Hypomineralization, Incisor Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nove de Julho University

São Paulo, 01504-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

observation

Behavioral

To perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Assessment of hypersensitivity in teeth with MIH: Visual analog scale (VAS)

    Time frame: Baseline

    The Wong-Baker Faces Pain Scale was initially developed for children to facilitate communication about pain. This scale uses a set of faces that ranges from a smiling expression (without pain) to a crying expression (worse pain possible), enabling children to indicate the intensity of their pain in a visually understandable way. The scale is used with children three years of age and older, facilitating communication and improving the assessment so that the management of the pain can be addressed.

  2. Schiff cold air sensitivity scale (SCASS)

    Time frame: Baseline

    The SCASS will be used to assess the child's response to the stimulus and will be scored as follows: 0 = no response to the stimulus; 1 = response to the stimulus, child considers stimulus painful; 2 = response to the stimulus, child moves away from stimulus; 3 = response to the stimulus, child moves away from the stimulus and asks for its immediate interruption.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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