Salivary Cortisol Levels in Children With Molar Incisor Hypomineralization

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Salivary Cortisol Level [Срок оценки: Day 1 (Immediately after the clinical dental examination)]

Вторичные конечные точки (2)

• Heart Rate [Срок оценки: Day 1 (During the clinical dental examination)]
• Oxygen Saturation (SpO₂) [Срок оценки: Day 1 (During the clinical dental examination)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• Lokman Hekim University, Faculty of Dentistry — Ankara

Публикации

• Schwendicke F, Elhennawy K, Reda S, Bekes K, Manton DJ, Krois J. Global burden of molar incisor hypomineralization. J Dent. 2018 Jan;68:10-18. doi: 10.1016/j.jdent.2017.12.002. Epub 2017 Dec 6. PMID 29221956
• Weerheijm KL, Duggal M, Mejare I, Papagiannoulis L, Koch G, Martens LC, Hallonsten AL. Judgement criteria for molar incisor hypomineralisation (MIH) in epidemiologic studies: a summary of the European meeting on MIH held in Athens, 2003. Eur J Paediatr Dent. 2003 Sep;4(3):110-3. PMID 14529329
• Jalevik B, Sabel N, Robertson A. Can molar incisor hypomineralization cause dental fear and anxiety or influence the oral health-related quality of life in children and adolescents?-a systematic review. Eur Arch Paediatr Dent. 2022 Feb;23(1):65-78. doi: 10.1007/s40368-021-00631-4. Epub 2021 Jun 10. PMID 34110616
• Contac LR, Pop SI, Dobreanu M, Oprica M, Voidazan S, Bica CI. Salivary Cortisol as a Biomarker for Assessing Fear and Anxiety in Patients with Molar-Incisor Hypomineralization. Diagnostics (Basel). 2025 Feb 17;15(4):489. doi: 10.3390/diagnostics15040489. PMID 40002640

Идентификаторы

NCT: NCT07389148 · 2025054

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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