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CompletedNCT06639815Updated Oct 15, 2024

Tooth Development in Molar Incisor Hypomineralisation

An observational study in Molar Incisor Hypomineralization, sponsored by Canan Bayraktar Nahir. Completed at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Canan Bayraktar Nahir · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
276
Ages
8 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Molar Incisor Hypomineralization

Keywords

  • children
  • dental age estimation
  • dental development
03

In context

Molar Hypomineralization

128 studies on the registry are indexed under Molar Hypomineralization; 43 are open to participants now.

This study's enrollment of 276 is above the median of 132 across 28 observational studies indexed under Molar Hypomineralization.

Browse Molar Hypomineralization studies →

Lead sponsor

Canan Bayraktar Nahir is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

must have parental consent must have high-quality panoramic radiographs

Exclusion criteria

Exclusion Criteria:

systemic disease tooth agenesis hyperdontia

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
276 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Group 1

    with molar incisor hypomineralization

    Other: clinical and radiographic examination

  • Group 2

    without molar incisor hypomineralization

    Other: clinical and radiographic examination

Interventions

  • Otherclinical and radiographic examination

    clinical and radiographic examination

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What researchers measure

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

    Time frame: 1 day

07

Study locations

1 site
  • Tokat Gaziosmanapaş University
    Tokat Province, Centre 60010, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 24042586 ↗

Individual participant data

Plan to share: Undecided — with the link to be prepared later

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Jun 2024, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2024
First posted
Oct 15, 2024
StartActual
Jun 1, 2023
Primary completionActual
Jun 1, 2024
CompletionActual
Jun 1, 2024
Last update
Oct 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06639815
Lead sponsor
Canan Bayraktar Nahir
Responsible party
Canan Bayraktar Nahir (Assistant Professor, Tokat Gaziosmanpasa University) — Sponsor-investigator
First posted
Oct 15, 2024
Start date
Jun 1, 2023
Primary completion
Jun 1, 2024
Completion
Jun 1, 2024
Last update
Oct 15, 2024

Study contacts

Esra Ergün, Research Assistant
principal investigator · Tokat Gaziosmanpaşa University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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