NCT06639815

Brief Summary

Molar incisor hypomineralization has been defined as a qualitative developmental enamel defect affecting one or more permanent first molars, often including the permanent incisors. The development of the teeth with the developmental defect remains unclear. The aim of this study is to evaluate tooth development in children with MIH using the Cameriere and Haavikko methods on panoramic radiographs and to determine the accuracy of these methods. The first null hypothesis of this study was that there would be no difference in tooth development between children with MIH and children with healthy structure of teeth, and the second null hypothesis was that Cameriere and Haavikko methods could estimate dental age with the equal accuracy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

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

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 9, 2024

Last Update Submit

October 11, 2024

Conditions

Keywords

childrendental age estimationdental development

Outcome Measures

Primary Outcomes (1)

  • Tooth development

    Distribution of children according to the group, chronological age and gender Evaluation of dental development of Group 1 and 2 according to gender and dental age estimation methods Comparison of chronological age and dental age estimated by two different dental age estimation methods according to groups and gender Comparison of chronological age and dental age according to different dental age methods, chronological age groups and presence of MIH in girls Comparison of chronological age and dental age according to different dental age methods, chronological age groups and presence of MIH in boys The agreement between dental age and chronological age in Group 1 and 2 according to gender and dental age estimation methods

    1 day

Study Arms (2)

Group 1

with molar incisor hypomineralization

Other: clinical and radiographic examination

Group 2

without molar incisor hypomineralization

Other: clinical and radiographic examination

Interventions

clinical and radiographic examination

Group 1Group 2

Eligibility Criteria

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

Children who apply to Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pedodontics due to any dental problem.

You may qualify if:

  • must have parental consent must have high-quality panoramic radiographs

You may not qualify if:

  • systemic disease tooth agenesis hyperdontia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanapaş University

Tokat Province, Centre, 60010, Turkey (Türkiye)

Location

Related Publications (1)

  • Tunc ES, Ulusoy AT, Bayrak S, Cankaya S. Dental development in children with severe molar-incisor hypomineralization in Samsun, Turkey. J Oral Sci. 2013 Sep;55(3):203-7. doi: 10.2334/josnusd.55.203.

    PMID: 24042586BACKGROUND

Related Links

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

X-Rays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Esra Ergün, Research Assistant

    Tokat Gaziosmanpaşa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 15, 2024

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations