Molar Incisor HypomineralizationNCT06951139
The Effect of Molar Incisor Hypomineralisation on the Stomatognathic System
An observational study of Molar Incisor Hypomineralization, run by Ozge Gungor at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine whether children with Molar Incisor Hypomineralization (MIH) are more likely to have problems with the jaw joint and chewing muscles. MIH is a dental condition where the enamel of the first molars and incisors is weaker than normal. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Ultrasound and Shear Wave Elastography
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 20 Mar 2025
- How long will I take part?
- 1 Day
- 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 9 to 14 years who visited the pediatric dentistry clinic for routine examinations. The study included both children diagnosed with Molar Incisor Hypomineralization (MIH) and healthy controls without MIH.
Who may be able to join
- Children aged between 9 and 14 years
- Good general health with no systemic disease
- Score of 3 or 4 on the Frankl Behavior Rating Scale
- No parafunctional oral habits (e.g., bruxism)
- No skeletal orthodontic abnormalities
- For the MIH group: presence of at least one first permanent molar diagnosed with MIH
- For the control group: absence of MIH diagnosis
Who cannot join
- Presence of advanced periodontal disease or tooth mobility
- History of facial trauma or jaw fracture
- Current medication use
- Inability to cooperate during clinical or ultrasonographic examinations
- Any condition that may affect temporomandibular joint structure or function
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry
Antalya, Konyaaltı, 07070
About this study
Official title: The Effect of Molar Incisor Hypomineralisation on the Stomatognathic System in Children: A Prospective Study
This study aims to examine whether children with Molar Incisor Hypomineralization (MIH) are more likely to have problems with the jaw joint and chewing muscles. MIH is a dental condition where the enamel of the first molars and incisors is weaker than normal. The researchers performed clinical examinations and ultrasound imaging to evaluate the thickness and elasticity of the chewing muscles. They also used a questionnaire to check for symptoms of temporomandibular disorders (TMD), such as jaw pain, headaches, and joint sounds.
Read the detailed description
This prospective clinical study investigates the potential impact of Molar Incisor Hypomineralization (MIH) on the stomatognathic system in children. MIH is a developmental enamel defect that affects the first permanent molars and incisors, resulting in weakened enamel and increased sensitivity. While MIH has been well documented in the context of dental health, its broader functional consequences remain underexplored. A total of 84 children aged 9-14 years participated in this study, including 43 with MIH and 41 healthy controls. The evaluation involved both clinical and ultrasonographic examinations. Temporomandibular disorders (TMD) were assessed using the Fonseca Anamnestic Index and through clinical parameters such as joint sounds, headaches, mandibular deviation/deflection, and mouth opening limitation. Ultrasound imaging, including shear wave elastography, was used to evaluate the thickness and elasticity of the masseter, temporalis, and sternocleidomastoid muscles, as well as the articular disc of the temporomandibular joint.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Ultrasound and Shear Wave Elastography
- Keywords
- elasticity, temporomandibular disorders, ultrasound, masticatory muscle
- Medical subject headings
- Molar Hypomineralization, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and Shear Wave ElastographyDiagnostic test
Non-invasive diagnostic imaging techniques used to assess the stomatognathic system. Ultrasound was performed to measure the thickness of the masseter, temporalis, and sternocleidomastoid muscles, as well as the articular disc of the temporomandibular joint. Shear Wave Elastography was used to evaluate the elasticity (stiffness) of the same muscles and joint structures in kilopascals. All evaluations were conducted at rest, using standardized positioning, and by the same experienced operator.
| Study group | Role | What they receive |
|---|---|---|
| MIH Group | This group includes children aged 9-14 years diagnosed with Molar Incisor Hypomineralization (MIH). Participants in this group underwent clinical and ultrasonographic evaluation to assess temporomandibular joint function and masticatory muscle properties. Receives: Diagnostic Test: Ultrasound and Shear Wave Elastography | |
| Control Group | This group includes healthy children aged 9-14 years without a diagnosis of Molar Incisor Hypomineralization (MIH). Participants were evaluated using the same clinical and ultrasonographic procedures as the MIH group. Receives: Diagnostic Test: Ultrasound and Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of temporomandibular disorders (TMD) in children with MIH
The presence of TMD was assessed in both the MIH and control groups using the Fonseca Anamnestic Index and clinical examination. TMD diagnosis was based on signs such as joint sounds, deviation/deflection, headaches, and mouth opening limitation.
Measured: At the time of enrollment (single clinical visit)
Thickness of masticatory muscles in children with and without MIH
Ultrasound and shear wave elastography were used to evaluate the thickness (in millimeters) of the masseter, temporalis, and sternocleidomastoid muscles bilaterally in both groups. Mean values were calculated and compared.
Measured: At the time of enrollment (single clinical visit)
Elasticity of masticatory muscles in children with and without MIH
Ultrasound and shear wave elastography were used to evaluate the elasticity (in kilopascals) of the masseter, temporalis, and sternocleidomastoid muscles bilaterally in both groups. Mean values were calculated and compared.
Measured: At the time of enrollment (single clinical visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start10 Mar 2025
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ozge Gungor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ozge Gungor, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951139
- Sponsor's protocol ID
- TBAEK-75
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Molar Incisor Hypomineralisation on the Stomatognathic System in Children: A Prospective Study
- ClinicalTrials.gov ID
- NCT06951139
- Acronym / sponsor ID
- TBAEK-75
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- elasticity, temporomandibular disorders, ultrasound, masticatory muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ozge GungorUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 30 Apr 2025 (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.
This study aims to examine whether children with Molar Incisor Hypomineralization (MIH) are more likely to have problems with the jaw joint and chewing muscles. MIH is a dental condition where the enamel of the first molars and incisors is weaker than normal. The researchers performed clinical examinations and ultrasound imaging to evaluate the thickness and elasticity of the chewing muscles. They also used a questionnaire to check for symptoms of temporomandibular disorders (TMD), such as jaw pain, headaches, and joint sounds.
Detailed description
This prospective clinical study investigates the potential impact of Molar Incisor Hypomineralization (MIH) on the stomatognathic system in children. MIH is a developmental enamel defect that affects the first permanent molars and incisors, resulting in weakened enamel and increased sensitivity. While MIH has been well documented in the context of dental health, its broader functional consequences remain underexplored. A total of 84 children aged 9-14 years participated in this study, including 43 with MIH and 41 healthy controls. The evaluation involved both clinical and ultrasonographic examinations. Temporomandibular disorders (TMD) were assessed using the Fonseca Anamnestic Index and through clinical parameters such as joint sounds, headaches, mandibular deviation/deflection, and mouth opening limitation. Ultrasound imaging, including shear wave elastography, was used to evaluate the thickness and elasticity of the masseter, temporalis, and sternocleidomastoid muscles, as well as the articular disc of the temporomandibular joint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIH Group | – | Diagnostic Test: Ultrasound and Shear Wave ElastographyThis group includes children aged 9-14 years diagnosed with Molar Incisor Hypomineralization (MIH). Participants in this group underwent clinical and ultrasonographic evaluation to assess temporomandibular joint function and masticatory muscle properties. |
| Control Group | – | Diagnostic Test: Ultrasound and Shear Wave ElastographyThis group includes healthy children aged 9-14 years without a diagnosis of Molar Incisor Hypomineralization (MIH). Participants were evaluated using the same clinical and ultrasonographic procedures as the MIH group. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 9 to 14 years who visited the pediatric dentistry clinic for routine examinations. The study included both children diagnosed with Molar Incisor Hypomineralization (MIH) and healthy controls without MIH.
Key inclusion criteria (7 listed)
- Children aged between 9 and 14 years
- Good general health with no systemic disease
- Score of 3 or 4 on the Frankl Behavior Rating Scale
- No parafunctional oral habits (e.g., bruxism)
- No skeletal orthodontic abnormalities
Key exclusion criteria (5 listed)
- Presence of advanced periodontal disease or tooth mobility
- History of facial trauma or jaw fracture
- Current medication use
- Inability to cooperate during clinical or ultrasonographic examinations
- Any condition that may affect temporomandibular joint structure or function
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 |
|---|---|---|
| Ultrasound and Shear Wave ElastographyNon-invasive diagnostic imaging techniques used to assess the stomatognathic system. Ultrasound was performed to measure the thickness of the masseter, temporalis, and sternocleidomastoid muscles, as well as the articular disc of the temporomandibular joint. Shear Wave Elastography was used to evaluate the elasticity (stiffness) of the same muscles and joint structures in kilopascals. All evaluations were conducted at rest, using standardized positioning, and by the same experienced operator. | Diagnostic test | Control Group, MIH Group |
Primary outcome
Prevalence of temporomandibular disorders (TMD) in children with MIH
Time frame: At the time of enrollment (single clinical visit)
The presence of TMD was assessed in both the MIH and control groups using the Fonseca Anamnestic Index and clinical examination. TMD diagnosis was based on signs such as joint sounds, deviation/deflection, headaches, and mouth opening limitation.
Thickness of masticatory muscles in children with and without MIH
Time frame: At the time of enrollment (single clinical visit)
Ultrasound and shear wave elastography were used to evaluate the thickness (in millimeters) of the masseter, temporalis, and sternocleidomastoid muscles bilaterally in both groups. Mean values were calculated and compared.
Elasticity of masticatory muscles in children with and without MIH
Time frame: At the time of enrollment (single clinical visit)
Ultrasound and shear wave elastography were used to evaluate the elasticity (in kilopascals) of the masseter, temporalis, and sternocleidomastoid muscles bilaterally in both groups. Mean values were calculated and compared.
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 30 Apr 2025.
- Individual participant dataSharing planned: No
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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 Incisor Hypomineralization, run by Ozge Gungor at 1 site in Turkey (Türkiye).
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 7 inclusion and 5 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 30 Apr 2025. 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 Turkey (Türkiye). 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?
Prevalence of temporomandibular disorders (TMD) in children with MIH (time frame: At the time of enrollment (single clinical visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2025.