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

21 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

45

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

    • Canton of Basel-City
      • Basel, Canton of Basel-City, Suíça, 4058
        • Recrutamento
        • University Centre for Dental Medicine
        • Contato:
        • Contato:
        • Subinvestigador:
          • Sangeetha Ramalingam, med.dent

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Colour of the defect
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Diretor de estudo: Carlalberta Verna, Professor Dr.med.dent., University of Basel

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

9 de janeiro de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

21 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de julho de 2026

Primeira postagem (Real)

27 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

This has not been discussed and decided yet

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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