Molar Incisor HypomineralizationNCT07389148
Salivary Cortisol Levels in Children With Molar Incisor Hypomineralization
An observational study of Molar Incisor Hypomineralization, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jan 2026to 26 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Lokman Hekim University, Faculty of Dentistry
Ankara, Ankara, 06510
About this study
Official title: 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 91 children aged 8 to 12 years will participate in the study, including 50 children diagnosed with MIH and 41 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.
Read the 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.
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar incisor hypomineralization, Salivary cortisol, Dental anxiety, Physiological stress, Children, Pediatric dentistry
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Salivary Cortisol Level
Salivary cortisol concentration measured immediately after the routine clinical dental examination as an objective biomarker of physiological stress.
Measured: Day 1 (Immediately after the clinical dental examination)
Secondary outcomes (2)
Heart Rate
Heart rate measured using a pulse oximeter during the routine clinical dental examination to assess physiological stress response.
Measured: 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.
Measured: Day 1 (During the clinical dental examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start26 Jan 2026
- Primary completion26 Mar 2026
- Study completion26 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Hamide Comert, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389148
- Sponsor's protocol ID
- 2025054
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the pediatric nature of the study and ethical considerations regarding participant confidentiality.
Publications
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.
PubMed 29221956Weerheijm 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.
PubMed 14529329Jalevik 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.
PubMed 34110616Contac 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.
PubMed 40002640
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salivary Cortisol Levels and Physiological Stress Parameters in Children With Molar Incisor Hypomineralization: A Comparative Observational Study
- ClinicalTrials.gov ID
- NCT07389148
- Acronym / sponsor ID
- 2025054
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar incisor hypomineralization, Salivary cortisol, Dental anxiety, Physiological stress, Children, Pediatric dentistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 26 Apr 2026 (actual)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 91 children aged 8 to 12 years will participate in the study, including 50 children diagnosed with MIH and 41 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Heart Rate
Time frame: Day 1 (During the clinical dental examination)
Oxygen Saturation (SpO₂)
Time frame: Day 1 (During the clinical dental examination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 29221956Schwendicke 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.
- Background: PubMed 14529329Weerheijm 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.
- Background: PubMed 34110616Jalevik 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.
- Background: PubMed 40002640Contac 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the pediatric nature of the study and ethical considerations regarding participant confidentiality.
Related trials for Molar Incisor Hypomineralization
Active, not recruiting
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
Molar Incisor Hypomineralization
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Molar-Incisor Hypomineralization and Resin Infiltration
Molar Incisor Hypomineralization
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Molar Incisor Hypomineralization, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Cortisol Level (time frame: Day 1 (Immediately after the clinical dental examination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07389148, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.