The Effect of Molar Incisor Hypomineralisation on the Stomatognathic System

Completed

• Conditions: Molar Incisor Hypomineralization

• Registration Number: NCT06951139
• Lead Sponsor: Ozge Gungor

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.

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 Timeline

• Study Start: 2025-03-10
• Primary Completion: 2025-03-20
• Study Completion: 2025-03-20
• Study First Submitted: 2025-03-28
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of temporomandibular disorders (TMD) in children with MIH	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	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	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.

Trial Locations

Locations (1)

Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry; 🇹🇷 Antalya, Konyaaltı, Turkey