Association Between Molar Incisor Hypomineralization And Type I Diabetes Milletus.

Molar Incisor Hypomineralization Clinical Trial

Official title:

Association Between Molar Incisor Hypomineralization And Type I Diabetes Milletus: A Cross Sectional Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06342089
• Other study ID #: NCT06342089
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: mariam samir fahmy, masters
• Phone: 01226493173
• Email: mariam.auob[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• Determine the association between molar incisor hypomineralization and type I diabetes millutes, its severity and treatment need via clinical examination of children with type I diabetes millutes .

• Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth.

• Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken.

• The severity and treatment needs of each case with MIH will be recorded in patient's chart.

• The results of the study will be regularly monitored by the supervisors who will have full access to these results.

Description:

• This cross-sectional study will be carried out by recruiting a sample of participants previously diagnosed with type I diabetes millutes.

• Details regarding participant diagnosis and treatment of type I diabetes millutes will be obtained from medical records. This includes date and the age of the child on diagnosis type I diabetes millutes, and a recent HbA1c level analysis within three months of the dental examination.

• A disposable diagnostic set (mirror, probe) were used for each child to examine the four first permanent molars , the four maxillary ,the four mandibular incisors and second primary molars to detect the presence of molar incisor hypomineralization and its severity and scores will be recorded in the chart then it will be correlated with treatment need.

• The teeth affected with molar incisor hypomineralization will be treated according to the recommendations of European academy of pediatric dentistry and the intervention will be recorded in patient's chart.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 238
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

Inclusion Criteria:

• Patient aged 8 to 14 years and diagnosed with types I diabetes milletus.

• Eruption of all 4 first permanent molars.

• Acceptance to participate.

Exclusion Criteria:

• Presence of orthodontic appliance.

• Patient with any other type of enamel defect.

• Patients with any other systemic conditions rather than types I diabetes milletus that may affect tooth development.

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Diabetes Mellitus, Type 1
• Molar Incisor Hypomineralization

Intervention

Other:
• Type I diabetes milletus
the exposure is type I diabetes milletus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (5)

Cingolani R, Stolz W, Ploog K. Electronic states and optical transitions in modulation-doped n-type GaxIn1-xAs/AlxIn1-xAs multiple quantum wells. Phys Rev B Condens Matter. 1989 Aug 15;40(5):2950-2955. doi: 10.1103/physrevb.40.2950. No abstract available. — View Citation

Ghanim A, Silva MJ, Elfrink MEC, Lygidakis NA, Marino RJ, Weerheijm KL, Manton DJ. Molar incisor hypomineralisation (MIH) training manual for clinical field surveys and practice. Eur Arch Paediatr Dent. 2017 Aug;18(4):225-242. doi: 10.1007/s40368-017-0293-9. Epub 2017 Jul 18. — View Citation

Lygidakis NA, Garot E, Somani C, Taylor GD, Rouas P, Wong FSL. Best clinical practice guidance for clinicians dealing with children presenting with molar-incisor-hypomineralisation (MIH): an updated European Academy of Paediatric Dentistry policy document. Eur Arch Paediatr Dent. 2022 Feb;23(1):3-21. doi: 10.1007/s40368-021-00668-5. Epub 2021 Oct 20. — View Citation

Mast P, Rodrigueztapia MT, Daeniker L, Krejci I. Understanding MIH: definition, epidemiology, differential diagnosis and new treatment guidelines. Eur J Paediatr Dent. 2013 Sep;14(3):204-8. — View Citation

Steffen R, Kramer N, Bekes K. The Wurzburg MIH concept: the MIH treatment need index (MIH TNI) : A new index to assess and plan treatment in patients with molar incisior hypomineralisation (MIH). Eur Arch Paediatr Dent. 2017 Oct;18(5):355-361. doi: 10.1007/s40368-017-0301-0. Epub 2017 Sep 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between molar incisor Hypomineralization and type I diabetes milletus	The association will be measured according to the diagnostic criteria of molar incisor Hypomineralization established by European Academy of Pediatric Dentistry.; Measuring unit: binary	one year
Secondary	Severity of molar incisor Hypomineralization among among a group of children with type I diabetes milletus.	the severity will be measured according to:European Academy of Paediatric Dentistry (EAPD) criteria.; Measuring unit: Categorical	one year
Secondary	Treatment need	The treatment need will be measured according to: treatment need index Measuring unit: Categorical l	one year