- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07727200
Correlation Between Colour of Defect and Enamel Breakdown in First Permanent Molars With Molar Incisor Hypomineralisation (MIH) (MIH)
Molar-Incisor Hypomineralisation (MIH): Correlation Between Colour of Defect and Enamel Breakdown
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Eirini Stratigaki, Dr.med.dent
- Telefonní číslo: +41 61 555 33 89
- E-mail: eirini.stratigaki@unibas.ch
Studijní záloha kontaktů
- Jméno: Sibylle Haas
- Telefonní číslo: +41 61 555 33 65
- E-mail: sibylle.haas@uzb.ch
Studijní místa
-
-
Canton of Basel-City
-
Basel, Canton of Basel-City, Švýcarsko, 4058
- Nábor
- University Centre for Dental Medicine
-
Kontakt:
- Sibylle Haas
- Telefonní číslo: +41 61 555 33 65
- E-mail: sibylle.haas@uzb.ch
-
Kontakt:
- Eirini Stratigaki, Dr.med.dent.
- Telefonní číslo: +41 61 555 33 89
- E-mail: eirini.stratigaki@unibas.ch
-
Dílčí vyšetřovatel:
- Sangeetha Ramalingam, med.dent
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Colour of the defect
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Carlalberta Verna, Professor Dr.med.dent., University of Basel
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MIH UZB 2024-02231
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .