Cortisol and stress responses in children with molar incisor hypomineralization
Evaluation of Salivary Cortisol Levels and Physiological Stress Parameters in Children With Molar Incisor Hypomineralization: A Comparative Observational Study
This study will measure salivary cortisol, heart rate, and oxygen levels to see if children aged 8–12 with MIH have higher physiological stress during a routine dental exam than children without MIH.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | Lokman Hekim University Government |
| Locations | 1 site (Ankara, Ankara) |
| Trial ID | NCT07389148 on ClinicalTrials.gov |
What this trial studies
This prospective observational study compares physiological stress markers in 90 children aged 8–12, including 45 with MIH and 45 healthy controls. Heart rate and oxygen saturation are recorded at predefined time points during a routine dental examination, and saliva is collected immediately afterward using a non-invasive absorption method to measure cortisol. All procedures are performed under standardized clinical conditions to reduce external influences on stress responses. The comparative design aims to provide objective data on whether MIH is associated with heightened physiological stress during dental visits.
Who should consider this trial
Good fit: Children aged 8 to 12 years who can cooperate with a routine dental exam, diagnosed with MIH by EAPD criteria or healthy without MIH, with parent or guardian written consent are eligible.
Not a fit: Children with systemic, hormonal, or metabolic diseases or those taking medications that affect cortisol or cardiovascular measures are excluded and unlikely to benefit from the study's findings.
Why it matters
Potential benefit: If differences are found, the findings could help dentists recognize physiological stress in children with MIH and guide more individualized, anxiety-reducing care.
How similar studies have performed: Behavioral research suggests increased dental anxiety in children with MIH, but objective studies using salivary cortisol and physiological measures in this population are limited, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged between 8 and 12 years. * Children diagnosed with molar incisor hypomineralization (MIH) according to the European Academy of Paediatric Dentistry (EAPD) criteria or healthy children without MIH. * Ability to cooperate sufficiently to complete the clinical dental examination and study procedures. * Written informed consent obtained from a parent or legal guardian. Exclusion Criteria: * Presence of systemic, hormonal, or metabolic diseases. * Regular use of medications known to affect salivary cortisol levels or cardiovascular parameters (e.g., corticosteroids, beta-blockers). * History of systemic conditions that may influence stress response. * Refusal of participation by the child or parent/legal guardian.
Where this trial is running
Ankara, Ankara
- Lokman Hekim University, Faculty of Dentistry — Ankara, Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Hamide Comert, DDS, PhD
- Email: hamide.comert@lokmanhekim.edu.tr
- Phone: +90 538 024 63 30
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.