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Correlation Between Colour of Defect and Enamel Breakdown in First Permanent Molars With Molar Incisor Hypomineralisation (MIH) (MIH)

2026年7月21日 更新者:Dr.med.dent. Eirini Stratigaki、University of Basel

Molar-Incisor Hypomineralisation (MIH): Correlation Between Colour of Defect and Enamel Breakdown

Cheese molars (MIH) can be recognized not only by their colour abnormalities but also by the enamel breakdown. Clinical management of those teeth may become challenging by the chronic hypersensitivity, that makes various steps during treatment, such as pain control or light curing of any type of composite restorations, difficult or even impossible, despite profound local anaesthesia. The aim of this study is to determine the relationship between colour of the defect and loss of ename in the affected teeth. A correlation between colour of the defect and risk of enamel breakdown could enable early prognosis leading to preventive measures in order to delay or even avoid completely any breakdown of the enamel. Children diagnosed with MIH on their first permanent molars of different severity are matched to children with sound molars. They are identified by the annual school dental check-up and are invited to take part in the study. The children will be invited to the university dental clinic via letter for the first appointment. Upon parental consent, the teeth will be photographed and scanned on the first appointment. Three follo-up appointments will be organised in order to take pictures and scan again the teeth. The baselne scan of the tetth will be compared to the scans of the subsequent appointments in order to measure the level of enamel breakdown and correlate it to the colour of the defect.

調査の概要

詳細な説明

Aim of the study is the correlation between the colour of the enamel defect and enamel breakdown in young first permanent molars. Children diagnosed with MIH from the onset of eruption of the first permanent molar, matched by age with children with sound first permanent molars are investigated. Children screened by the school dental services of Basel-Stadt as well children attending the department of children and adolescents (KJZM) of the University Centre for Dental Medicine in Basel (UZB), diagnosed with MIH on one or more first permanent molars receive a letter of information- invitation to be seen in the department of children and adolescents (KJZM). The control group consists of fit and healthy children 5-8 years old, who attend the department of children and adolescents (KJZM-UZB) for their regular dental check-ups. A written informed consent will be obtained from the parents/legal guardians.

Colour definition:

The exact colour determination of the teeth will be carried out as follows: the teeth are photographed with a canon SLR camera. (Canon EOS 80D; Canon inc. Japan), a ringflash (Macro Ring Lite MR-14EXII; Canon) and a macro lens (EF-S 60mm 1:2:8 USM; Canon) will be used. All camera settings (1/250, aperture F20, iso-sensitivity 100 and a fixed white balance AWBW (white priority), flash intensity +/-0) and the tooth-lens distances (25 cm) are standardized by one operator (VM, SR). A colour reference card (grey card) is photographed together with the tooth of interest in order to identify and equalize the colour deviations. The resulting photo will be uploaded to the Adobe Photoshop 6 and the values of the RGB code (0-255 for each of the three colours) will be determined. The tolerance range is set to +/- 10. If the 3 colours are within the tolerance, the photo can be used to determine the colour of the tooth to be examined. The darkest part of the tooth is then determined. The degree of darkness is indicated by a number between zero and one hundred, where L=100 is white and L=0 is black (Wiedrichs et al. 2023).

Degree of enamel loss will be investigated and measured as follows:

The teeth will be scanned using the iTero 5D Plus intraoral scanner in the first appointment and then at 3, 6 and 9 months. The obtained stl file is optimised for the subsequent digital superimposition procedures. The distances between surface points of the two digital models (initial scan vs scan at 3months, initial scan vs scan at 6 months and initial scan vs scan at 9 months) will be converted to root mean square (RMS) values that assess the mean value of errors in the comparison of two datasets with an identical coordinate system. The RMS values represent the data of trueness or loss of enamel. The results of deviation analysis will be complemented by visualisation of the 3D colour-coded maps in which the yellow-to-red fields indicate that distance values are greater than the positive limits while turquoise-to-dark blue fields indicate that distance values are smaller than the negative limits. The range of tolerance (green color) is set at ± 0.05 mm, which means that the software report surface differences in the color-coded maps only beyond this range.

研究の種類

観察的

入学 (推定)

45

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Canton of Basel-City
      • Basel、Canton of Basel-City、スイス、4058
        • 募集
        • University Centre for Dental Medicine
        • コンタクト:
        • コンタクト:
        • 副調査官:
          • Sangeetha Ramalingam, med.dent

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

Children screened by the school dental services of Basel-Stadt as well children attending the department of children and adolescents (KJZM) of the University Centre for Dental Medicine in Basel (UZB), diagnosed with MIH on one or more first permanent molars will receive a letter of information- invitation to be seen in the department of children and adolescents (KJZM).

The control group will consist of fit and healthy children 5-8 years old, who attend the department of children and adolescents (KJZM-UZB) for their regular dental check-ups.

説明

MIH Study Group

Inclusion Criteria:

  • Children between 5 to 8 years with MIH molars with or without hypersensitivity according to the MIH-TN Index (Bekes et al 2016)
  • Children with first molars in occlusion
  • Children fit and healthy

Exclusion Criteria:

  • MIH first permanent molars that have already received any kind of dental treatment
  • Children diagnosed with HSPM (hypomineralised second primary molars)
  • Children older than 8 years - Children younger than 5 years
  • Children with any cranio-facial and/or other developmental dental defects
  • Children diagnosed with parafunctions (attrition/ erosion)
  • Children and/or parents who did not consent to the study
  • Children with MIH teeth that show clinically visible enamel loss during the eruption
  • Children without the first molars in occlusion

Non- MIH Control Group

Inclusion Criteria:

  • Children between 5 to 8 years with no clinically affected molars- Page 4 of 5
  • Children fit and healthy

Exclusion Criteria:

  • Children who have already received any kind of dental treatment on their permanent or primary teeth
  • Children diagnosed with MIH or any other disease of the teeth
  • Children older than 8 years
  • Children younger than 5 years
  • Children with any cranio-facial and/or other developmental dental defects
  • Children diagnosed with parafunctions (attrition/ erosion)
  • Children and/or parents who did not consent to the study

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
MIH Group
MIH Group Children 5 to 8 yrs old diagnosed with Molar Incisor Hypomineralisation on one or more first permanent molars
Non MIH Healthy Group
Children 5 to 8 yrs old with no signs of Molar Incisor Hypomineralisation on any of their first permanent molars

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Colour of the defect
時間枠:Baseline appointment until the 9-months follow-up appointment
A colour reference card (grey card) is photographed together with the tooth of interest in order to identify and equalize the colour deviations. The resulting photo will be uploaded to the Adobe Photoshop 6. and the values of the RGB code (0-255 for each of the three colours) will be determined. The tolerance range is set to +/- 10. If the 3 colours are within the tolerance, the photo can be used to determine the colour of the tooth to be examined. The darkest part of the tooth is then determined. The degree of darkness is indicated by a number between zero and one hundred, where L=100 is white and L=0 is black (Wiedrichs et al. 2023).
Baseline appointment until the 9-months follow-up appointment
Enamel breakdown
時間枠:From enrollment to the last follow-up appointment at 9 months
The teeth will be scanned using the iTero Element 5D Plus. The distances between surface points of the two digital models (baseline vs 3months, baseline vs 6months, baseline vs 9months) will be converted to root mean square (RMS) values that assess the mean value of errors in the comparison of two datasets with an identical coordinate system. The RMS values quantify trueness and enamel loss. the deviation analysis will be complemented by 3D colour-coded maps.Yellow-to-red areas indicate positive deviations, where the measured distance values exceed th upper tolerance limit, whereas turquoise-to-dark areas inidicate negative deviations, in which the measured distance values fall below the lower tolerance limit. The range of tolerance (green colour) is set at ± 0.05 mm, which means that the software report surface differences in the color-coded maps only beyond this range.
From enrollment to the last follow-up appointment at 9 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Carlalberta Verna, Professor Dr.med.dent.、University of Basel

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月9日

一次修了 (推定)

2026年12月31日

研究の完了 (推定)

2027年3月31日

試験登録日

最初に提出

2026年7月21日

QC基準を満たした最初の提出物

2026年7月21日

最初の投稿 (実際)

2026年7月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月27日

QC基準を満たした最後の更新が送信されました

2026年7月21日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

This has not been discussed and decided yet

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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