Association Between Molar Incisor Hypomineralization And Type I Diabetes Milletus. (MIH and TIDM)

April 4, 2024 updated by: Mariam Samir Fahmy Auob, Cairo University

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

  • 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

238

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
the exposure is type I diabetes milletus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between molar incisor Hypomineralization and type I diabetes milletus
Time Frame: one year

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of molar incisor Hypomineralization among among a group of children with type I diabetes milletus.
Time Frame: one year

the severity will be measured according to:European Academy of Paediatric Dentistry (EAPD) criteria.

Measuring unit: Categorical
one year
Treatment need
Time Frame: one year
The treatment need will be measured according to: treatment need index Measuring unit: Categorical l
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT06342089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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