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Correlation Between Colour and Hypersensitivity of First Permanent Molars With Molar Incisor Hypomineralisation (MIH)

21 de julio de 2026 actualizado por: Dr.med.dent. Eirini Stratigaki, University of Basel

Molar-Incisor Hypomineralisation (MIH): Correlation Between Colour of the Defect and Hypersensitivity in Young First Permanent Molars

Cheese molars (MIH: molar incisor hypomineralisation) can be recognized not only by their colour abnormalities but also by their hypersensitivity. Clinical management of these teeth may become challenging by the chronic hypersensitivity, which makes various steps of a treatment, such as pain control or light curing of any type of composite restorations, difficult or even impossible, despite profound local anesthesia. Hypersensitivity can be detected by the clinician based on the patient's statements or reaction. On the other hand, colours and structural abnormalities can be easily assessed by visual inspection. The aim of this study is to determine the relationship between hypersensitivity and the colour of the enamel defect on young first permanent molars. A correlation between colour of the defect and hypersensitivity could enable early prognosis leading to preventive measures in order to delay, amplify or even avoid the onset of the symptoms. 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 as well as investigated for hypersensitivity through a gentle air blast.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

Aim of the study is the correlation between the colour of the enamel defect and hypersensitivity 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 Photoshop Adobe 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).

The sensitivity of the teeth will be assessed by using the Schiff Cold air Sensitivity Scale (Schiff et al 1994). Teeth will be dried by an air blast defined at 5 bar. Prior to the examination patient will be introduced to the procedure by "tell-show-do" method. Based on the patient's reaction, the sensitivity to the air shock is divided into:

0 no reaction to the stimulus

  1. reaction, but continuing with the stimulus possible
  2. reaction, moving, demanding termination
  3. painful, immediate abandonment of procedure In addition to the sensitivity, assessed by the main investigator (VM or SR), the Wong-Baker Faces Pain Rating Scale (Wong-Baker FACES Foundation 2022) will be applied. The scale consists of six faces representing different expressions of pain, ranging from a laughing face with no pain (score 0) to a crying face with severe pain (score 10). Each face has a numerical score from 0 to 10 indicating pain intensity. Children will be asked to select the face that best describes their current pain experience.

Each appointment lasts a maximum of 30 minutes. In addition to the Schiff-Cold-Air-Scale-Test, hypersensitivity is also determined using the Face-Pain-Scale.

Tipo de estudio

De observación

Inscripción (Estimado)

45

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Sibylle Haas
  • Número de teléfono: +41 61 555 33 65
  • Correo electrónico: sibylle.haas@uzb.ch

Ubicaciones de estudio

    • Canton of Basel-City
      • Basel, Canton of Basel-City, Suiza, 4058
        • Reclutamiento
        • University Centre for Dental Medicine
        • Contacto:
        • Contacto:
        • Sub-Investigador:
          • Vivienne Mazenauer, med.dent

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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
  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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 one or more first permanent molars

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Colour of the defect
Periodo de tiempo: Baseline investigation at first 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 investigation at first appointment
Hypersensitivity
Periodo de tiempo: Baseline appointment

The sensitivity of the teeth will be assessed by using the Schiff Cold air Sensitivity Scale (Schiff et al 1994). Teeth will be dried by an air blast defined at 5 bar. Prior to the examination patient will be introduced to the procedure by "tell-show-do" method. Based on the patient's reaction, the sensitivity to the air shock is divided into:

0 no reaction to the stimulus

  1. reaction, but continuing with the stimulus possible
  2. reaction, moving, demanding termination
  3. painful, immediate abandonment of procedure In addition to the sensitivity, assessed by the main investigator (VM or SR), the Wong-Baker Faces Pain Rating Scale (Wong-Baker FACES Foundation 2022) will be applied. The scale consists of six faces representing different expressions of pain, ranging from a laughing face with no pain (score 0) to a crying face with severe pain (score 10). Each face has a numerical score from 0 to 10 indicating pain intensity. Children will be asked to select the face that best describes t
Baseline appointment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Carlalberta Verna, Professor Dr.med.dent., University of Basel
  • Investigador principal: Eirini Stratigaki, Dr.med.dent, University of Basel

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de enero de 2026

Finalización primaria (Estimado)

31 de agosto de 2026

Finalización del estudio (Estimado)

31 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

21 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2026

Publicado por primera vez (Actual)

27 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

This has not been decided yet

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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