Tooth Development in Molar Incisor Hypomineralisation

NCT ID: NCT06639815

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Molar Incisor Hypomineralization

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

with molar incisor hypomineralization

clinical and radiographic examination

Intervention Type OTHER

clinical and radiographic examination

Group 2

without molar incisor hypomineralization

clinical and radiographic examination

Intervention Type OTHER

clinical and radiographic examination

Interventions

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clinical and radiographic examination

clinical and radiographic examination

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

must have parental consent must have high-quality panoramic radiographs

Exclusion Criteria

systemic disease tooth agenesis hyperdontia
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canan Bayraktar Nahir

OTHER

Sponsor Role lead

Responsible Party

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Canan Bayraktar Nahir

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Esra Ergün, Research Assistant

Role: PRINCIPAL_INVESTIGATOR

Tokat Gaziosmanpaşa University

Locations

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Tokat Gaziosmanapaş University

Tokat Province, Centre, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 24042586 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/24042586/

Tunc ES, Ulusoy AT, Bayrak S, Cankaya S. Dental development in children with severe molar-incisor hypomineralization in Samsun, Turkey. J Oral Sci 2013;55:203-207.

Other Identifiers

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23-KAEK-113

Identifier Type: -

Identifier Source: org_study_id

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