Orofacial Functions in Individuals With and Without Molar Incisor Hypomineralization

NCT06692257 | Completed

• 1 other identifier: Orofacial functions
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Molar Hypomineralization, Incisor

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

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

  Baseline

• Schiff cold air sensitivity scale (SCASS)

  Baseline

Study Arms (2)

Individuals without MIH

All permanent molars without indices compatible with MIH

Behavioral: Observation

Individuals with MIH

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

Behavioral: Observation

Interventions

Observation BEHAVIORAL

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; Individuals without MIH

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, São Paulo, 01504-001, Brazil

Location

Related Publications (1)

• Pernomiam FC, Mandetta ARH, Ribeiro CDPV, Camargo CCB, Romano IMF, Sobral APT, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Duran CCG, Motta LJ, Bussadori SK. Orofacial functions with emphasis on breathing and chewing patterns in individuals with and without molar incisor hypomineralisation: observational study protocol conducted in a dental clinic in Brazil. BMJ Open. 2025 Jun 4;15(6):e101725. doi: 10.1136/bmjopen-2025-101725.

  PMID: 40467310 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

BR (1)