Salivary Cortisol Levels 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

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.

Study Overview

• Status: Recruiting
• Conditions: Molar Incisor Hypomineralization

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Hamide Comert, DDS, PhD; Phone Number: +90 538 024 63 30; Email: hamide.comert@lokmanhekim.edu.tr
• Study Contact Backup: Name: Merve Ozdemir, DDS, PhD; Phone Number: +90 543 670 26 94; Email: merveozdemir@lokmanhekim.edu.tr

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06510
      • Recruiting
      • Lokman Hekim University, Faculty of Dentistry
      • Contact: Hamide Comert, DDS, PhD; Phone Number: +90 538 024 63 30; Email: hamide.comert@lokmanhekim.edu.tr
      • Contact: Merve Ozdemir, DDS, PhD; Phone Number: +90 543 670 26 94; Email: merveozdemir@lokmanhekim.edu.tr
      • Principal Investigator: Hamide Comert, DDS, PhD
      • Sub-Investigator: Merve Ozdemir, DDS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children aged 8 to 12 years attending the Department of Pediatric Dentistry. Participants include children diagnosed with molar incisor hypomineralization and age-matched healthy control children without MIH.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
MIH Group; Children aged 8 to 12 years diagnosed with molar incisor hypomineralization (MIH) according to the European Academy of Paediatric Dentistry (EAPD) criteria. Participants in this group undergo a routine clinical dental examination without any therapeutic intervention. Physiological stress parameters, including salivary cortisol levels, heart rate, and oxygen saturation, are assessed during the dental visit.
Control Group; Age- and sex-matched healthy children aged 8 to 12 years without a diagnosis of molar incisor hypomineralization. Participants undergo a routine clinical dental examination without any therapeutic intervention. Salivary cortisol levels, heart rate, and oxygen saturation are measured using the same protocol as applied to the MIH group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Cortisol Level	Salivary cortisol concentration measured immediately after the routine clinical dental examination as an objective biomarker of physiological stress.	Day 1 (Immediately after the clinical dental examination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate measured using a pulse oximeter during the routine clinical dental examination to assess physiological stress response.	Day 1 (During the clinical dental examination)
Oxygen Saturation (SpO₂)	Peripheral oxygen saturation measured using a pulse oximeter during the routine clinical dental examination as a physiological parameter associated with stress response.	Day 1 (During the clinical dental examination)

Collaborators and Investigators

• Sponsor: Lokman Hekim University
• Collaborators: The Scientific and Technological Research Council of Turkey

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 26, 2026
• Primary Completion (Estimated): March 26, 2026
• Study Completion (Estimated): April 26, 2026

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Children; Salivary cortisol; Pediatric dentistry; Dental anxiety; Molar incisor hypomineralization; Physiological stress
• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Molar Hypomineralization
• Other Study ID Numbers: 2025054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to the pediatric nature of the study and ethical considerations regarding participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No