Clinical trial NCT06639815: Tooth Development in Molar Incisor Hypomineralisation
Official title: Evaluation of Tooth Development in Molar Incisor Hypomineralization with Cameriere and Haavikko Methods for Dental Age Estimation: a Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Molar Incisor Hypomineralization
Keywords: children
dental age estimation
dental development
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 276
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children who apply to Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pedodontics due to any dental problem.

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.

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.

Eligibility criteria: Inclusion Criteria:

must have parental consent must have high-quality panoramic radiographs

Exclusion Criteria:

systemic disease tooth agenesis hyperdontia

Primary outcomes:
measure: Tooth development
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanapaş University
state: Centre
Study officials:
affiliation: Tokat Gaziosmanpaşa University
name: Esra Ergün, Research Assistant
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.