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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04475419
Other study ID # 01008322329
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date December 31, 2020

Study information

Verified date July 2020
Source Cairo University
Contact Eman m elmasry, PHD
Phone 01001651946
Email Mahmoued_dentist3@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns


Description:

MIH or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria:

.Children with molar incisor hypo mineralization 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:
preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary pain after the restoration .Binary (yes or No) questionnaire 12 MONTHS
Secondary Acceptability of the treatment Binary (yes or No) questionnaire 12 months
Secondary restoration quality Score index (FDI criteria; criterion marginal adaptation) 12 months
Secondary health-related quality of life changes by the therapies measured as difference in Child Perceptions Questionnaire CPQ 8-10/11-14) 12 months
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