Orofacial Functions in Individuals With and Without Molar Incisor Hypomineralization

April 17, 2026 updated by: Sandra Kalil Bussadori, University of Nove de Julho

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01504-001
        • Nove de Julho University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study will be conducted with children 6 to 12 years of age enrolled at the pediatric dentistry clinic of Nove de Julho University. The participants will be assessed in a single session during a visit to the clinic. All assessments will be performed by the same researcher.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Individuals without MIH
All permanent molars without indices compatible with MIH
Behavioral: Observation
To perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH.
Individuals with MIH
At least one permanent molar with indices compatible with MIH (code 2, 21, 22 and 3 - Ghanim criteria)
Behavioral: Observation
To perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Orofacial functions

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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