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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04701320
Other study ID # OPER 3-3-6
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date July 7, 2019
Est. completion date August 9, 2021

Study information

Verified date January 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In geriatric patients, will the clinical performance of nano hydroxyapatite reinforced glass ionomer be better than conventional glass ionomer cement in treatment of root caries lesions over one year follow up?


Description:

Glass carbomers are commercialized under the name of GCP Glass Fill, this material may be an interesting subject of research, certainly its bioactive properties as the manufacturer claims this material to have remineralizing properties. If this is the case, GCP Glass Fill could be an interesting reference material for further bioactivity studies


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date August 9, 2021
Est. primary completion date July 7, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - • = 50 years old - Males or females. - Community-dwelling - Have five or more of their own teeth - With = 1 root caries lesion Exclusion Criteria: - • Patients younger than 50 years old - Disabilities. - Systemic diseases or severe medically compromised.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Conventional glass ionomer
Conventional glass ionomer with enhanced mechanical and esthetic proberties
Nano hydroxyapatite reinforced glass ionomer
Nanohydroxyapatite reinforced glass ionomer restorative material with enhanced mechanical proberties and chemical adhesion to tooth structure

Locations

Country Name City State
Egypt Faculty of dentistry Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical restorative performance Service (USHPS) Change in the clinical behavior of the restoration (e.g. anatomical contour, shade match, secondary caries) using modified United State Public Health clinical evaluation assessment method Service (USHPS) Change from the baseline at 3, 6 and12 months
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