Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer in Treatment of Root Caries in Geriatric Patients

Dental Restoration Failure Clinical Trial

Official title:

Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer Versus Conventional Glass Ionomer in Treatment of Root Caries in Geriatric Patients: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04701320
• Other study ID #: OPER 3-3-6
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Dental Restoration Failure
• Root Caries

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