Clinical trial NCT06342089: Prevalence And Severity Of Molar Incisor Hypomineralization Among A Group Of Children With Type I Diabetes Milletus.
Official title: Prevalence And Severity Of Molar Incisor Hypomineralization Among A Group Of Children With Type I Diabetes Milletus:A Cross Sectional Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Molar Incisor Hypomineralization
Keywords: Molar Incisor Hypomineralization (MIH)
Type I diabetes milletus(TIDM)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 238
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * This cross-sectional study will be carried out by recruiting a sample of participants previously diagnosed with types I diabetes milletus aged from( 8-14) accept to participate.
* All permanent molars must be erupted as the diagnosis of molar incisor hypomineralization required at least one permanent molar involved .
* The patient mustn't have any other medical conditions nor orthodontic appliance that may affect the enamel quality

Brief summary: * Determine the prevalence of molar incisor hypomineralization among a group of children with 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: prevalence of molar incisor Hypomineralization among among a group of children with type I diabetes milletus.
timeFrame: one year
Secondary outcomes:
measure: Severity of molar incisor Hypomineralization among among a group of children with type I diabetes milletus.
timeFrame: one year
measure: Treatment need
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.
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.
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.
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.