An observational study in Molar Incisor Hypomineralisation, Enamel Breakdown and Colour of Defect, sponsored by University of Basel. Recruiting at 1 site in Switzerland. Open to participants aged 5 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by University of Basel · Observational
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.
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.
133 studies on the registry are indexed under Molar Hypomineralization; 46 are open to participants now.
This study's planned enrollment of 45 is below the median of 129 across 29 observational studies indexed under Molar Hypomineralization.
Browse Molar Hypomineralization studies →University of Basel is the lead sponsor of 62 studies on the registry; 10 are open to participants now.
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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.
MIH Study Group
Inclusion Criteria:
Exclusion Criteria:
Non- MIH Control Group
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MIH Group Children 5 to 8 yrs old diagnosed with Molar Incisor Hypomineralisation on one or more first permanent molars
Children 5 to 8 yrs old with no signs of Molar Incisor Hypomineralisation on any of their first permanent molars
Colour of the defect
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).
Time frame: Baseline appointment until the 9-months follow-up appointment
Enamel breakdown
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.
Time frame: From enrollment to the last follow-up appointment at 9 months
Plan to share: No — This has not been discussed and decided yet
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