NCT04231019

Brief Summary

Molar incisor hypomineralization (MIH) is one of the developmental enamel defect which is characterized by demarcated, qualitative defects of enamel of systemic origin affecting one to four first permanent molars (FPMs) and frequently associated with incisor involvement. Similar lesions can be seen in second primary molars and their presence has been reported as a predictive factor for developing MIH. Although the exact etiology of MIH is unclear, it is likely to be multi-factorial. Possible etiological factors of MIH are systemic conditions as pneumonia, upper respiratory tract infections, asthma, otitis media, hypoxia, high fever, hypocalcemia and exposure to antibiotics as amoxicillin. The prevalence of MIH has been reported from several studies to be between 2.8 and 40.2 %, with the mean approximately 15 %. MIH is considered as a common clinical problem by several epidemiological studies from many countries. Clinical presentation of MIH can include white, creamy and yellow-brown opacities, irregular areas of post eruptive breakdown, which can be mistaken diagnosed as hypoplasia or atypical caries. The condition is usually associated with a high disease burden, leading to pain, infection and tooth loss. Teeth affected by MIH are at high risk of rapid caries development and progression, rapid wear and enamel breakdown. Severely affected enamel disintegrates under masticatory forces resulting in post-eruptive breakdown (PEB), which is also a characteristic feature of MIH-affected teeth. These teeth require treatment, ranging from prevention to restorations and extractions, often under general anesthesia. A multidisciplinary cooperation among clinicians is often required, particularly for extractions of first permanent molars, when orthodontic consequences need to be considered. To evaluate the effect of this condition, questionnaires of dentists and dental professionals have been carried out in various countries, including those in Europe, Australia and New Zealand, Malaysia, Iraq, Iran and Saudi Arabian. These have generally revealed that MIH has been frequently encountered in clinical practice, particularly by dental professionals who treat children and that there is a need for further training for the condition. To date dental clinicians' concerns regarding MIH have not been extensively assessed in Egypt.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 16, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

December 26, 2019

Last Update Submit

January 30, 2024

Conditions

Keywords

Molar incisor hypomineralizationGeneral dental practitionersPerceptionknowledgeOral health

Outcome Measures

Primary Outcomes (1)

  • knowledge of Egyptian dental practitioners regarding molar-incisor hypomineralization

    The tool used for measuring the primary outcome is a self-administered questionnaire that was fulfilled by the study participants

    1 year

Study Arms (1)

Dental practitioners (general, specialists or students)

Two self-administered questionnaires will be used in the study one to general practitioners and specialists and another one with a plain language describing the study will be distributed to the fifth year dental students in Egypt with total 1000 dentist to assess their knowledge, awareness and perception regarding MIH.

Other: self-administered questionnaire

Interventions

Self-administered questionnaires with plain language statements and brief description of the clinical features and photographs of MIH were used to determine the knowledge, awareness and perception regarding the prevalence, severity, etiology and treatment modalities of molar-incisor hypomineralization (MIH) among Egyptian fifth year dental students, general dental practitioners and dental specialists. There were two routes for delivering the questionnaire either as online questionnaire sent to the participants by email or as a hard copy that is hand delivered.

Dental practitioners (general, specialists or students)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Fifth year dental students, general dental practitioners and dental specialists.

You may qualify if:

  • Males and females.
  • Dental students should be at the fifth year.
  • All participants should be Egyptians.

You may not qualify if:

  • Dentists or dental students who refuse to participate in the study.
  • Any dentist without the Egyptian nationality even if they are studying in Egyptian universities or working in Egypt.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Related Publications (4)

  • Silva MJ, Alhowaish L, Ghanim A, Manton DJ. Knowledge and attitudes regarding molar incisor hypomineralisation amongst Saudi Arabian dental practitioners and dental students. Eur Arch Paediatr Dent. 2016 Aug;17(4):215-22. doi: 10.1007/s40368-016-0230-3. Epub 2016 May 12.

    PMID: 27172776BACKGROUND
  • Silva MJ, Scurrah KJ, Craig JM, Manton DJ, Kilpatrick N. Etiology of molar incisor hypomineralization - A systematic review. Community Dent Oral Epidemiol. 2016 Aug;44(4):342-53. doi: 10.1111/cdoe.12229. Epub 2016 Apr 28.

    PMID: 27121068BACKGROUND
  • Hussein AS, Ghanim AM, Abu-Hassan MI, Manton DJ. Knowledge, management and perceived barriers to treatment of molar-incisor hypomineralisation in general dental practitioners and dental nurses in Malaysia. Eur Arch Paediatr Dent. 2014 Oct;15(5):301-7. doi: 10.1007/s40368-014-0115-2. Epub 2014 Feb 26.

    PMID: 24569938BACKGROUND
  • Ghanim A, Morgan M, Marino R, Manton D, Bailey D. Perception of molar-incisor hypomineralisation (MIH) by Iraqi dental academics. Int J Paediatr Dent. 2011 Jul;21(4):261-70. doi: 10.1111/j.1365-263X.2011.01118.x. Epub 2011 Feb 20.

    PMID: 21332851BACKGROUND

MeSH Terms

Conditions

Molar HypomineralizationDental Enamel Hypoplasia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alaa Mo Yehia, Ass. Lec

    Faculty of Dentistry- Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2019

First Posted

January 18, 2020

Study Start

September 16, 2018

Primary Completion

October 22, 2019

Study Completion

December 23, 2019

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations