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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04369768
Other study ID # MIH restoration
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2020
Est. completion date August 2021

Study information

Verified date July 2020
Source Cairo University
Contact Sandra Nasr Fares
Phone 01225167030
Email dr.sandra.nasr@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the clinical outcome of using direct esthetic composite restorations and the use of preformed metal crowns in managing MIH cases among a group of Egyptian children.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria:

- Children with MIH in one fully erupted molar or more.

- Age ranging from 7-12 years.

- Cooperative children

- Good general health.

Exclusion Criteria:

- patients participating in other experiments.

- Patients with parents planning to move away within the following year.

- Patients with only mildly affected MIH molars that do not require extensive restorative treatment.

- MIH-affected molars that have a very poor prognosis and require extraction.

- First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta

Study Design


Intervention

Procedure:
restoration of permanent molars affected with MIH
restore MIH affected molars using direct composite or preformed metal crowns

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary treating hypersensitivity associated with MIH affected permanent molars by questioning the patient questioning the patient about hypersensitivity after performing treatment ( direct composite restorations and preformed metal crowns) one year
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