Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children From 8 to 12 Years Old in Dakahlia

Molar Incisor Hypomineralization Clinical Trial

— MIH  

Official title:

Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children Aged From Eight to Twelve Years Old in Dakahlia Governorate: A Cross Sectional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03583671
• Other study ID #: CEBD-CU-2018-06-22
• Status: Not yet recruiting
• Start date: November 2018
• Est. completion date: December 2019

Study information

• Verified date: June 2018
• Source: Cairo University
• Contact: Rana Mohamed EL-Abassery, Bds
• Phone: 01227003334
• Email: Rana.elabassiry[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to assess the prevalence of MIH among a group of Egyptian children aged from 8-12 years old in Dakahlia governorate schools.

Description:

• Clinical examination will be carried out in the school laboratory or an empty class, in day light, 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.

• An examination chart (Appendix 1) will be filled for each child including: date, name, age, address, gender, school, medical health and any previous dental treatment, followed by clinical examination to the four first permanent molars and the eight maxillary and mandibular incisors to detect the presence of MIH and its severity based on European Academy of Pediatric Dentistry (EAPD) criteria . To diagnose Molar Incisor Hypomineralization, at least one affected first permanent molar is required. Extracted first permanent molar will be recorded as affected if another first permanent molar has a defecting MIH

• Each child affected with MIH will be given a letter outlining his dental health status, to inform the parents and indicate the need for treatment.

Examination chart

Date:

Personal information:

Name: Age: Gender:

Address:

School:

Medical history:

Dental history:

Clinical examination:

8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8

8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8

Severity according to EAPD:

Code Description Severity 0 No defect

1. White or creamy demarcated opacities/mild Mild

2. Yellow or brown demarcated opacities Mild

3. a Enamel loss Moderate

3b Enamel and dentin loss Severe 3c Atypical large cavities extended to pulp and covering one or more tubercle Severe 4 Atypical restorations Severe 5 Extracted tooth Severe

Comments:

MIH: presence / absence Severity: Mild / Moderate /Severe

(Appendix 1)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6000
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Acceptance for participation in the study.

• Children aged from 8-12 years old.

• Eruption of at four first permanent molars.

• 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.

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

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	measuring method:clinical examination measuring unit: binary method	6 months
Secondary	Severity of Molar Incisor Hypomineralization	measuring method: clinical examination measuring unit:Modified index (based on European Academy of Pediatric Dentistry criteria 2003, 2009)	6 months