Salivary Cortisol Levels in Children With Molar Incisor Hypomineralization

NCT07389148 | Recruiting

• 1 other identifier: 2025054
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Molar Incisor Hypomineralization

Keywords

Molar incisor hypomineralization; Salivary cortisol; Dental anxiety; Physiological stress; Children; Pediatric dentistry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Heart Rate

  Day 1 (During the clinical dental examination)

• Oxygen Saturation (SpO₂)

  Day 1 (During the clinical dental examination)

Study Arms (2)

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.

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lokman Hekim University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Lokman Hekim University, Faculty of Dentistry

Ankara, Ankara, 06510, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples collected using an absorption-based method for cortisol analysis. Samples will not be used for genetic testing or DNA extraction.

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Hamide Comert, DDS, PhD

CONTACT

+90 538 024 63 30; hamide.comert@lokmanhekim.edu.tr

Merve Ozdemir, DDS, PhD

CONTACT

+90 543 670 26 94; merveozdemir@lokmanhekim.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Specialist in Pediatric Dentistry

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 5, 2026
• Study Start: January 26, 2026
• Primary Completion: March 26, 2026
• Study Completion: April 26, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)