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NCT Number: NCT06639815

Tooth Development in Molar Incisor Hypomineralisation

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokat Gaziosmanapaş University

Tokat Province, Centre, 60010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

must have parental consent must have high-quality panoramic radiographs

Exclusion criteria

systemic disease tooth agenesis hyperdontia

Treatment and study plan

clinical and radiographic examination

Other

clinical and radiographic examination

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Canan Bayraktar Nahir

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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