Tooth Development in Molar Incisor Hypomineralisation

October 11, 2024 updated by: Canan Bayraktar Nahir

Evaluation of Tooth Development in Molar Incisor Hypomineralization with Cameriere and Haavikko Methods for Dental Age Estimation: a Case-control Study

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.

Study Overview

Status

Completed

Detailed Description

This study was planned to evaluate tooth development in a cohort of 8- to 12-year-old children diagnosed with MIH who applied to the Department of Pedodontics, Faculty of Dentistry, Tokat Gaziosmanpaşa University, for dental examinations or treatment between June 1, 2023, and June 1, 2024.

The study group (Group 1) was determined according to gender and chronological age group from children who were diagnosed with MIH as a result of dental examination and met the inclusion criteria. The control group (Group 2) was selected from children matched to MIH cases according to gender and chronological age, without signs of hypomineralisation and met the inclusion criteria.

The chronological age of the children was calculated using Microsoft Excel 2013 (Microsoft, Redmond, WA, USA). The following formula was applied:

"[(date of panoramic radiography) - (documented date of birth)] / 365.25" Tooth development was determined on panoramic radiographs taken with a single device (J. Morita Mfg. Corp., Kyoto, Japan) using the Cameriere and Haavikko methods.

The data were analyzed using the IBM Statistical Package for the Social Sciences (SPSS for Windows, version 26.0, SPSS Inc., Chicago, IL, USA). Data from the two dental age estimation methods were analyzed for each gender and age group within Group 1 and Group 2. The Kolmogorov-Smirnov test was applied to assess normality. The Spearman correlation coefficient was employed to examine the relationship between chronological and dental age, and the Paired Samples T-test and Wilcoxon Signed-rank Test were used to compare the difference. The Independent Samples T-test and Mann-Whitney U test were utilized to compare chronological and dental age based on MIH presence. Intraclass Correlation Coefficient (ICC) was calculated to assess inter- and intra-observer reliability. Quantitative data are presented as mean ± standard deviation and median (minimum-maximum), while categorical data are presented as frequency (percentage). Statistical significance was set at the 0.05 level.

Study Type

Observational

Enrollment (Actual)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Centre
      • Tokat, Centre, Turkey, 60010
        • Tokat Gaziosmanapaş University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

must have parental consent must have high-quality panoramic radiographs

Exclusion Criteria:

systemic disease tooth agenesis hyperdontia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
with molar incisor hypomineralization
clinical and radiographic examination
Group 2
without molar incisor hypomineralization
clinical and radiographic examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth development
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Esra Ergün, Research Assistant, Tokat Gaziosmanpasa University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

with the link to be prepared later

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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