The Association Between MIH and HSPM

January 23, 2023 updated by: Yassmin Mohamed Abdelrahman, Cairo University
Aim of the Study Evaluate association between HSPM and MIH in Egyptian children. Record the prevalence of HSPM and MIH in Egyptian children

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Statement of the Problem:

Molar Incisor Hypomineralization (MIH) is defined as developmental qualitative defect of systemic origin, which affects one to four of first permanent molars and frequently associated with permanent incisors . The prevalence of MIH worldwide was reported from 2.4% to40.2% and clinical measures of MIH based on scientific criteria was established based on the European Academy of Pediatric Dentistry criteria to allow comparison between the findings of different studies .

The most commonly reported clinical problems for patients with MIH are hypersensitivity of teeth to various thermal and mechanical stimuli result in improper tooth brushing, plaque accumulation and rapid caries progression. Severely affected enamel shows post eruptive breakdown and such teeth require extensive treatment, ranging from prevention to restorations and extractions. MIH patients also have increased risk of developing dental fear and anxiety as well as behavior management problems added to the difficulty to achieve effective local anaesthesia which are related to chronic pulp inflammation from dentin exposure due to excessive enamel breakdown.

Rational As developmental of Second Primary Molar start at the same time as the development of the first permanent molars and incisor but the maturation of permanent teeth occur more slow. So when a systemic disturbance occur it affect second primary molar as well as first permanent molar and incisors.

Few studies test the association between hypomineralized second primary molar (HSPM) and MIH. While no study available on Egyptian children.

Study Type

Observational

Enrollment (Actual)

190

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

Study Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt, 11562
        • Cairo University

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

8 years to 9 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy children aged from 8 to 9 years attending outpatient clinic in Pediatric Dentistry Department, Faculty of Dentistry, Cairo University will be included in this study according to eligibility criteria

Description

Inclusion Criteria:

  • Children aged from 8 to 9 years.
  • Both genders.
  • No systemic health problems

Exclusion Criteria:

  • Children with extracted primary second molars and permanent incisors and molars.
  • Children with history of dental trauma.
  • Children with orthodontic bands or dental appliances

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

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of hypomineralized second primary molars.
Time Frame: 1 year
The percentage of children who has enamel defect on their second primary molars in the study
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the prevalence of Molar Incisor Hypomineralization
Time Frame: 1 year
The percentage of children who has enamel defect on their permenant molars and Incisors at this study
1 year

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Rania A Taha, Professor, Cairo U

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 (Actual)

June 1, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

April 12, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MIH and HSPM

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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