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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03233464
Other study ID # ARefaat
Secondary ID
Status Enrolling by invitation
Phase N/A
First received July 25, 2017
Last updated February 10, 2018
Start date May 2018
Est. completion date July 2018

Study information

Verified date February 2018
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

- One single operator will assess the prevalence of molar incisor hypomineralization and its Severity among a group of Egyptian children .


Description:

the study is about the prevalance of molar incisor hypomineralization and its severity among a group of Egyptian children aged 8-12 years old in Giza Governorate schools.

- Participants will be randomly selected from primary and preparatory schools in Giza governorate, seated in the school lap or an empty classroom.

- Clinical examination will be made in the daylight using disposable diagnostic sets (mirror, and explorer). No diagnostic radiographs will be taken.

- Prior to performing dental examination, index teeth including incisors and 1st permanent molars will be cleaned using a cotton roll.

- A dental explorer will be further used for cleaning molar fissures.

- The examiner carefully inspect the coronal part of the 1st permanent molars and permanent incisors for demarcated opacities.

- A specially made examination chart will be taken for the child including his name, age, address, gender, school, date, medical health and any previous dental treatment.

prevalance of molar incisor hypomineralization is measured by presence or absence.

severity is measured by Modified index based on European Academy of Paediatric Dentistry (EAPD) criteria


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 374
Est. completion date July 2018
Est. primary completion date June 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility Inclusion Criteria:

- schools in Giza Governorate.

- Positive patient acceptance for participation in the study.

- Patients who are apparently medically free from any systemic disease.

Exclusion Criteria:

- Uncooperative child.

- Children with appliances.

Study Design


Locations

Country Name City State
Egypt Aya Refaat Abd El-Ghaffar Giza,Egypt

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Salem K, Aziz D, Asadi M. Prevalence and Predictors of Molar Incisor Hypomineralization (MIH) among Rural Children in Northern Iran. Iran J Public Health. 2016 Nov;45(11):1528-1530. — View Citation

Yannam SD, Amarlal D, Rekha CV. Prevalence of molar incisor hypomineralization in school children aged 8-12 years in Chennai. J Indian Soc Pedod Prev Dent. 2016 Apr-Jun;34(2):134-8. doi: 10.4103/0970-4388.180438. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary molar incisor hypomineralization prevalance of molar incisor hypomineralization 20 mins
Secondary molar incisor hypomineralization severity of molar incisor hypomineralization 20 mins
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