NCT05779332

Brief Summary

Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
655

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

January 19, 2023

Last Update Submit

March 9, 2023

Conditions

Keywords

Molar Incisor Hypomineralizationoral healthMIHOral health related lif qualityChild Perceptions QuestionnaireOHRQoLCPQ

Outcome Measures

Primary Outcomes (3)

  • To determine the prevalence and etiology of MIH.

    A questionnaire was applied to the parents about the etiological factors and the prevalence of MIH was determined by oral examination.

    up to four months

  • To evaluate the impacts of MIH on oral health status.

    Oral health was evaluated by recording dmft (decayed, missing and filled teeth) and plaque index values.

    up to six months

  • To evaluate the impacts of MIH on OHRQoL.

    The impact of MIH on quality of life (OHRQoL) was measured with the Child Perception Questionnaire (CPQ8-10).

    up to six months

Interventions

Children's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Oral examination of children were conducted for presence and severity of MIH, dental caries experience and oral hygiene status.

Also known as: oral examination

Eligibility Criteria

Age9 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

9-year-old children who were enrolled in the primary schools in the city of Rize, Turkey.

You may qualify if:

  • Being 9-year-old,
  • Mentally and physically capable of completing the questionnaire,
  • Presence of fully erupted 4 permanent molars and 8 permanent incisors.

You may not qualify if:

  • Children were receiving orthodontic treatment during the examination,
  • Children had enamel hypoplasia or developmental defects,
  • Children had amelogenesis imperfecta or dental fluorosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sema Aydinoğlu

Rize, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar HypomineralizationPrecursor Cell Lymphoblastic Leukemia-LymphomaDental CariesDental PlaqueStomatognathic Diseases

Interventions

Diagnosis, Oral

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesTooth DemineralizationDental Deposits

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 19, 2023

First Posted

March 22, 2023

Study Start

February 1, 2020

Primary Completion

April 30, 2020

Study Completion

June 15, 2020

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations