Correlation Between Colour of Defect and Enamel Breakdown in First Permanent Molars With Molar Incisor Hypomineralisation (MIH)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-8
SponsorUniversity of Basel
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
45 Participants
are grouped into 2 trial groupsGroup A: MIH Group
Group B: Non MIH Healthy Group
Trial outcomes
Primary outcomes
1
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 appointment2
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 monthsSponsors and contacts
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Source ClinicalTrials.gov