NCT06081491

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

October 7, 2023

Last Update Submit

December 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 36532319BACKGROUND

Related Links

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Soaad A Moniem, Proffesor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Sarah M Sadek, bachelor

CONTACT

Reem Wahby, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student principal investigator

Study Record Dates

First Submitted

October 7, 2023

First Posted

October 13, 2023

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

December 29, 2023

Record last verified: 2023-12