Molar Hypomineralization, IncisorNCT06692257
Orofacial Functions in Individuals With and Without Molar Incisor Hypomineralization
An observational study of Molar Hypomineralization, Incisor, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Hypomineralization, Incisor
- What is being tested?
- Observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2025to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Molar Hypomineralization, Incisor
- Being tested
- Observation
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationBehavioural
To perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH.
| Study group | Role | What they receive |
|---|---|---|
| Individuals without MIH | All permanent molars without indices compatible with MIH Receives: Behavioral: Observation | |
| Individuals with MIH | At least one permanent molar with indices compatible with MIH (code 2, 21, 22 and 3 - Ghanim criteria) Receives: Behavioral: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
Assessment of hypersensitivity in teeth with MIH: Visual analog scale (VAS)
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.
Measured: Baseline
Schiff cold air sensitivity scale (SCASS)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Mar 2025
- Primary completion1 Jul 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Molar Hypomineralization, IncisorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692257
- Sponsor's protocol ID
- Orofacial functions
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40467310
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orofacial Functions With Emphasis on Breathing and Chewing Patterns in Individuals With and Without Molar Incisor Hypomineralization: Observational Study Protocol
- ClinicalTrials.gov ID
- NCT06692257
- Acronym / sponsor ID
- Orofacial functions
- Conditions
- Molar Hypomineralization, Incisor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals without MIH | – | Behavioral: ObservationAll permanent molars without indices compatible with MIH |
| Individuals with MIH | – | Behavioral: ObservationAt least one permanent molar with indices compatible with MIH (code 2, 21, 22 and 3 - Ghanim criteria) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationTo perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH. | Behavioural | Individuals with MIH, Individuals without MIH |
Primary outcome
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.
2 secondary outcomes
Assessment of hypersensitivity in teeth with MIH: Visual analog scale (VAS)
Time frame: Baseline
Schiff cold air sensitivity scale (SCASS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 40467310Pernomiam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Molar Hypomineralization, Incisor, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of orofacial function (NOT-S) - (score from 0 to 12) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06692257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.