Orofacial Functions With Emphasis on Breathing and Chewing Patterns in Individuals With and Without Molar Incisor Hypomineralization: Observational Study Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Nove de Julho
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Assessment of orofacial function (NOT-S) - (score from 0 to 12)
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Individuals without MIH
All permanent molars without indices compatible with MIH
Intervention: Observation (Behavioral)
Individuals with MIH
At least one permanent molar with indices compatible with MIH (code 2, 21, 22 and 3 - Ghanim criteria)
Intervention: Observation (Behavioral)
Outcomes
Primary Outcomes
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
- Assessment of hypersensitivity in teeth with MIH: Visual analog scale (VAS)(Baseline)
- Schiff cold air sensitivity scale (SCASS)(Baseline)
Investigators
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho