The Effect of Molar Incisor Hypomineralisation on the Stomatognathic System

NCT06951139 | Completed

• 1 other identifier: TBAEK-75
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Molar Incisor Hypomineralization

Keywords

elasticity; temporomandibular disorders; ultrasound; masticatory muscle

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At the time of enrollment (single clinical visit)

Study Arms (2)

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.

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.

Diagnostic Test: Ultrasound and Shear Wave Elastography

Interventions

Ultrasound and Shear Wave Elastography DIAGNOSTIC_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.

Control Group; MIH Group

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ozge Gungor: lead

Study Sites (1)

Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization; Temporomandibular Joint Disorders

Interventions

Ultrasonography

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; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, DDS, Assoc. Prof. Dr.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 30, 2025
• Study Start: March 10, 2025
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)