- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06081491
Association Between Molar-Incisor Hypomineralization, Maternal Stress and Anxiety: A Cross-Sectional Study.
Association Between Molar-Incisor Hypomineralization, Maternal Stress and Anxiety in a Group of Pediatric Patients : A Cross-Sectional Study.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sarah M Sadek, bachelor
- Phone Number: 01143342788
- Email: sarah.sadek@dentistry.cu.edu.eg
Study Contact Backup
- Name: Reem Wahby, Lecturer
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parents perceive proper oral health education about opacities and higher chance of development of carious lesions associated with MIH as an oral health problem
Time Frame: baseline
|
Questions answered by the parents to improve their capability in detecting the condition, Binary questions (yes/no)
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Soaad A Moniem, Proffesor, Cairo University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIH and stress
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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