Salivary Cortisol Levels in Children With Molar Incisor Hypomineralization
ConditionMolar Incisor Hypomineralization
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-12
SponsorLokman Hekim University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 2 trial groupsGroup A: MIH Group
Group B: Control Group
Trial outcomes
Primary outcomes
1
Salivary Cortisol Level
Salivary cortisol concentration measured immediately after the routine clinical dental examination as an objective biomarker of physiological stress.
Time frame
Day 1 (Immediately after the clinical dental examination)Secondary outcomes
1
Heart Rate
Heart rate measured using a pulse oximeter during the routine clinical dental examination to assess physiological stress response.
Time frame
Day 1 (During the clinical dental examination)2
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.
Time frame
Day 1 (During the clinical dental examination)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lokman Hekim University
Lead sponsor
The Scientific and Technological Research Council of Turkey
Collaborator
Source ClinicalTrials.gov