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NCT Number: NCT07389148

Salivary Cortisol Levels in Children With Molar Incisor Hypomineralization

Molar incisor hypomineralization (MIH) is a developmental condition that affects the enamel of permanent molars and incisors in children and may cause tooth sensitivity, discomfort, and difficulties during dental treatment. These problems can increase dental anxiety and lead to physiological stress responses during dental visits.

The purpose of this observational study is to evaluate physiological stress responses in children with MIH by measuring salivary cortisol levels, heart rate, and oxygen saturation, and to compare these findings with those of children without MIH. A total of 90 children aged 8 to 12 years will participate in the study, including 45 children diagnosed with MIH and 45 healthy control participants.

Participation involves no treatment or intervention beyond a routine clinical dental examination. Heart rate and oxygen saturation will be measured during the dental visit, and saliva samples will be collected immediately after the examination using a non-invasive method to assess cortisol levels. The results of this study may contribute to a better understanding of stress responses in children with MIH and support the development of more individualized and anxiety-sensitive dental care approaches.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lokman Hekim University, Faculty of Dentistry

Ankara, 06510, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hamide Comert, DDS, PhD

CONTACT

[email protected]

+90 538 024 63 30

Hamide Comert, DDS, PhD

PRINCIPAL_INVESTIGATOR

Merve Ozdemir, DDS, PhD

CONTACT

[email protected]

+90 543 670 26 94

Merve Ozdemir, DDS, PhD

SUB_INVESTIGATOR

About this study

Molar incisor hypomineralization (MIH) is a developmental enamel defect that may lead to hypersensitivity, discomfort during dental procedures, and increased dental anxiety in affected children. While behavioral aspects of anxiety in children with MIH have been investigated, objective assessment of physiological stress responses in this population remains limited.

This prospective observational study is designed to evaluate physiological stress responses in children with MIH by assessing salivary cortisol levels in conjunction with non-invasive physiological parameters recorded during a routine dental examination. The study includes a comparative design involving children with an MIH diagnosis and healthy control participants.

All procedures are conducted under standardized clinical conditions to minimize external factors that may influence stress responses. Saliva samples are collected using a non-invasive absorption-based method immediately after the dental examination to assess cortisol levels. Physiological parameters are recorded at predefined time points during the dental visit to capture stress-related changes associated with the clinical environment.

The study aims to provide objective data on stress-related physiological responses in children with MIH, which may contribute to improved understanding of anxiety-related mechanisms and support the development of more individualized, child-centered dental care strategies.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. Salivary Cortisol Level

    Time frame: Day 1 (Immediately after the clinical dental examination)

    Salivary cortisol concentration measured immediately after the routine clinical dental examination as an objective biomarker of physiological stress.

Secondary outcomes

  1. Heart Rate

    Time frame: Day 1 (During the clinical dental examination)

    Heart rate measured using a pulse oximeter during the routine clinical dental examination to assess physiological stress response.

  2. Oxygen Saturation (SpO₂)

    Time frame: Day 1 (During the clinical dental examination)

    Peripheral oxygen saturation measured using a pulse oximeter during the routine clinical dental examination as a physiological parameter associated with stress response.

Study contacts

Contact information is provided by the study sponsor or research team.

Hamide Comert, DDS, PhD

CONTACT

[email protected]

+90 538 024 63 30

Merve Ozdemir, DDS, PhD

CONTACT

[email protected]

+90 543 670 26 94

Sponsors and collaborators

Lead sponsor

Lokman Hekim University

Other Gov

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Evaluation of Salivary Cortisol Levels and Physiological Stress Parameters in Children With Molar Incisor Hypomineralization: A Comparative Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 9, 2026

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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