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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04420520
Other study ID # CEBD-CU-2020-05-13
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 20, 2020
Est. completion date May 20, 2021

Study information

Verified date June 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Determining the Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools via clinical examination.

Participants from primary and preparatory schools in Fayoum governorate will be included in the study and Clinical examination will be carried out in the school laboratory or an empty class, in day light for both genders.

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 results of the study will be regularly monitored by the supervisors who will have full access to these results.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 135
Est. completion date May 20, 2021
Est. primary completion date April 20, 2021
Accepts healthy volunteers
Gender All
Age group 6 Years to 14 Years
Eligibility Inclusion Criteria:

- Acceptance for participation in the study.

- Eruption of four first permanent molars.

- Eruption of four permanent maxillary and mandibular incisors.

- Both genders.

Exclusion Criteria:

- Uncooperative children.

- Children with orthodontic appliances.

- Children with systemic diseases which may affect teeth development.

- Children suffering from any other type of enamel defect as enamel hypoplasia and amelogenesis imperfecta.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Molar Incisor Hypomineralization Prevalence of Molar Incisor Hypomineralization done via clinical examination using a disposable diagnostic set in the school laboratory or an empty class, in day light. Through study completion, an average of 1 year
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