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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06081491
Other study ID # MIH and stress
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2024
Est. completion date October 2025

Study information

Verified date December 2023
Source Cairo University
Contact Sarah M Sadek, bachelor
Phone 01143342788
Email sarah.sadek@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to evaluate the association between Molar-Incisor Hypomineralization, Maternal Stress and anxiety in a group of pediatric patients.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 174
Est. completion date October 2025
Est. primary completion date September 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
diagnosis
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline
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