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

2026년 7월 21일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

45

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Canton of Basel-City
      • Basel, Canton of Basel-City, 스위스, 4058
        • 모병
        • University Centre for Dental Medicine
        • 연락하다:
        • 연락하다:
        • 부수사관:
          • Sangeetha Ramalingam, med.dent

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Colour of the defect
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Carlalberta Verna, Professor Dr.med.dent., University of Basel

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 1월 9일

기본 완료 (추정된)

2026년 12월 31일

연구 완료 (추정된)

2027년 3월 31일

연구 등록 날짜

최초 제출

2026년 7월 21일

QC 기준을 충족하는 최초 제출

2026년 7월 21일

처음 게시됨 (실제)

2026년 7월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 21일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

This has not been discussed and decided yet

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다