NCT06342089

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
238

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

March 26, 2024

Last Update Submit

July 12, 2024

Conditions

Keywords

Molar Incisor Hypomineralization (MIH)Type I diabetes milletus(TIDM)

Outcome Measures

Primary Outcomes (1)

  • prevalence of molar incisor Hypomineralization among among a group of children with type I diabetes milletus.

    The prevalence will be measured according to the diagnostic criteria of molar incisor Hypomineralization established by European Academy of Pediatric Dentistry. Measuring unit: percentage

    one year

Secondary Outcomes (2)

  • Severity of molar incisor Hypomineralization among among a group of children with type I diabetes milletus.

    one year

  • Treatment need

    one year

Study Arms (1)

children with type I diabetes milletus

•Patient aged 8 to 14 years and diagnosed with type I diabetes milletus with erupted all 4 first permanent molars.

Other: Type I diabetes milletus

Interventions

the exposure is type I diabetes milletus

children with type I diabetes milletus

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • Patient aged 8 to 14 years and diagnosed with types I diabetes milletus.
  • Eruption of all 4 first permanent molars.
  • Acceptance to participate.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 9992226BACKGROUND
  • 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.

    PMID: 28721667BACKGROUND
  • 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.

    PMID: 34669177BACKGROUND
  • 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.

    PMID: 28913739BACKGROUND
  • 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.

    PMID: 24295005BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

mariam samir fahmy, masters

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at the Department of Pediatric Dentistry

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 2, 2024

Study Start

September 1, 2024

Primary Completion

November 1, 2024

Study Completion

May 1, 2025

Last Updated

July 16, 2024

Record last verified: 2024-07