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NCT Number: NCT06951139

The Effect of Molar Incisor Hypomineralisation on the Stomatognathic System

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.

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Key information

Conditions

Molar Incisor Hypomineralization Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniomandibular Disorders Dental Enamel Hypomineralization Developmental Defects of Enamel Jaw Diseases Joint Diseases Mandibular Diseases Molar Hypomineralization Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities Temporomandibular Joint Disorders Tooth Abnormalities Tooth Diseases

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ozge Gungor

Other

Registry information

Official study title

The Effect of Molar Incisor Hypomineralisation on the Stomatognathic System in Children: A Prospective Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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