Molar Incisor HypomineralizationNCT06081491
Association Between Molar-Incisor Hypomineralization, Maternal Stress and Anxiety: A Cross-Sectional Study.
An observational study of Molar Incisor Hypomineralization, run by Cairo University.
Trial summary
This study aims to evaluate the association between Molar-Incisor Hypomineralization, Maternal Stress and anxiety in a group of pediatric patients. 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
- What is being tested?
- diagnosis
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Oct 2025
- 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: Pediatric patients age range of 8 to 12 years with completely erupted at least one first permanent molar and whose parents agree their participation with signed consent will be diagnosed for MIH according to EAPD diagnostic criteria
Who may be able to join
- Pediatric Patients with completely erupted at least one first permanent molar with MIH, based on a validated diagnostic criteria
- Children age range from 8 and 12 years
- Parents who agree and signed the consent for their children participation
Who cannot join
- -Enamel defects only limited to the Permanent incisors; as the term MIH was chosen to always highlight the fact that molars are involved regularly in this condition, opacities on incisors only may relate to another origin of the defect and should not be referred to as MIH.
Trial locations and contacts
No sites are listed yet.
Reem Wahby, Lecturer contact
About this study
Official title: Association Between Molar-Incisor Hypomineralization, Maternal Stress and Anxiety in a Group of Pediatric Patients : A Cross-Sectional Study.
This study aims to evaluate the association between Molar-Incisor Hypomineralization, Maternal Stress and anxiety in a group of pediatric patients.
Read the detailed description
Molar incisor hypomineralization is a medical global condition characterised by a qualitative defect in the enamel mineralization affecting the first permanent molar teeth predominantly, and with or without the involvement of incisor teeth. MIH have various and major clinical challenges. Clinically the lesion appears with well demarcated opacity and porous with a color that ranges from white, creamy or yellow to brownish. Thus differ in its severity from mild to severe. The OHRQoL is a fundamental part of our children's general health and well-being but with the condition mentioned above their eating, sleeping, social interaction, self-esteem is being minimized and so the analysis of the etiological factors should be carried out.
Worldwide the prevalence of this condition, MIH was found to be from 2.4 to 40%, the reason behind this huge range difference is the use of different indices, diagnostic criteria, variability between examiners, lack of standardized methods of recording lesions and different age groups, while recent studies in Egypt reported 2.3% of MIH in a group of Egyptian children from 8 to 12 years in Cairo. Moreover, 878 million people across the world were MIH-affected and 17.5 million new cases are identified each year according to a study published 02 August 2022 in Egypt.
Despite the worldwide increasing interest in the causes of MIH, there is still insufficient evidence to verify the etiological factors of this condition, especially stress and anxiety. There is a potential relationship between stress and MIH, as glucocorticoids mainly cortisol have receptors on ameloblasts and so further research and population-based studies are urgently required to evaluate the prevalence of MIH and its association with stress.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- diagnosis
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosisDiagnostic test
Pediatric patients within the inclusion criteria will be diagnosed for MIH by the primary investigator and the questionnaire will be filled with face to face interviews with their parents
What is being measured
The primary outcome is the main question the study is designed to answer.
MIH occurrence due to stressful events
Questionnaire(Brejawi MS etal .2022), Multiple choice questions , (yes or no if yes the participant should choose the degree:not at all/ very little/little/alot) where alot means it has the greatest impact of stress on the child.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Mahmoud Mohamed Sadek, Cairo University
- Investigators
- Soaad A Moniem, Proffesor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081491
- Sponsor's protocol ID
- MIH and stress
- Status last verified
- Dec 2023
- First submitted
- 7 Oct 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brejawi MS, Venkiteswaran A, Ergieg SMO, Sabri BM. Correlation between Molar-Incisor Hypomineralization, Stress, and Family Functioning. J Int Soc Prev Community Dent. 2022 Oct 31;12(5):547-553. doi: 10.4103/jispcd.JISPCD_105_22. eCollection 2022 Sep-Oct.
PubMed 36532319
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Molar-Incisor Hypomineralization, Maternal Stress and Anxiety in a Group of Pediatric Patients : A Cross-Sectional Study.
- ClinicalTrials.gov ID
- NCT06081491
- Acronym / sponsor ID
- MIH and stress
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 13 Oct 2023 (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.
This study aims to evaluate the association between Molar-Incisor Hypomineralization, Maternal Stress and anxiety in a group of pediatric patients.
Detailed description
Molar incisor hypomineralization is a medical global condition characterised by a qualitative defect in the enamel mineralization affecting the first permanent molar teeth predominantly, and with or without the involvement of incisor teeth. MIH have various and major clinical challenges. Clinically the lesion appears with well demarcated opacity and porous with a color that ranges from white, creamy or yellow to brownish. Thus differ in its severity from mild to severe. The OHRQoL is a fundamental part of our children's general health and well-being but with the condition mentioned above their eating, sleeping, social interaction, self-esteem is being minimized and so the analysis of the etiological factors should be carried out.
Worldwide the prevalence of this condition, MIH was found to be from 2.4 to 40%, the reason behind this huge range difference is the use of different indices, diagnostic criteria, variability between examiners, lack of standardized methods of recording lesions and different age groups, while recent studies in Egypt reported 2.3% of MIH in a group of Egyptian children from 8 to 12 years in Cairo. Moreover, 878 million people across the world were MIH-affected and 17.5 million new cases are identified each year according to a study published 02 August 2022 in Egypt.
Despite the worldwide increasing interest in the causes of MIH, there is still insufficient evidence to verify the etiological factors of this condition, especially stress and anxiety. There is a potential relationship between stress and MIH, as glucocorticoids mainly cortisol have receptors on ameloblasts and so further research and population-based studies are urgently required to evaluate the prevalence of MIH and its association with stress.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients age range of 8 to 12 years with completely erupted at least one first permanent molar and whose parents agree their participation with signed consent will be diagnosed for MIH according to EAPD diagnostic criteria
Key inclusion criteria (3 listed)
- Pediatric Patients with completely erupted at least one first permanent molar with MIH, based on a validated diagnostic criteria
- Children age range from 8 and 12 years
- Parents who agree and signed the consent for their children participation
Key exclusion criteria (1 listed)
- -Enamel defects only limited to the Permanent incisors; as the term MIH was chosen to always highlight the fact that molars are involved regularly in this condition, opacities on incisors only may relate to another origin of the defect and should not be referred to as MIH.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosisPediatric patients within the inclusion criteria will be diagnosed for MIH by the primary investigator and the questionnaire will be filled with face to face interviews with their parents | Diagnostic test | – |
Primary outcome
MIH occurrence due to stressful events
Time frame: baseline
Questionnaire(Brejawi MS etal .2022), Multiple choice questions , (yes or no if yes the participant should choose the degree:not at all/ very little/little/alot) where alot means it has the greatest impact of stress on the child.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Background: PubMed 36532319Brejawi MS, Venkiteswaran A, Ergieg SMO, Sabri BM. Correlation between Molar-Incisor Hypomineralization, Stress, and Family Functioning. J Int Soc Prev Community Dent. 2022 Oct 31;12(5):547-553. doi: 10.4103/jispcd.JISPCD_105_22. eCollection 2022 Sep-Oct.
- Molar Incisor Hypomineralization, Prevalence, and EtiologyLink provided by the sponsor.
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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.
Reem Wahby, Lecturer contact
Soaad A Moniem, Proffesor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Molar Incisor Hypomineralization, run by Cairo University.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah M Sadek, bachelor (01143342788, sarah.sadek@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MIH occurrence due to stressful events (time frame: baseline). 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 NCT06081491, which also lists 1 linked publication.
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 29 Dec 2023.