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

January 6, 2021 updated by: Reham nabil mahmoud, Cairo University

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

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?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 002
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glass carbomer
Nano hydroxyapatite Reinforced Glass Ionomer that results in chemical bond formation with tooth structure mimic that of enamel tissue
Drug: Nano hydroxyapatite reinforced glass ionomer
Nanohydroxyapatite reinforced glass ionomer restorative material with enhanced mechanical proberties and chemical adhesion to tooth structure
Other Names:
  • Glass carbomer
Active Comparator: Fuji ix
Conventional Glass Ionomer cement fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics, a wear resistant, self-adhesive
Drug: Conventional glass ionomer
Conventional glass ionomer with enhanced mechanical and esthetic proberties
Other Names:
  • Fujiix gc corporation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical restorative performance Service (USHPS)
Time Frame: Change from the baseline at 3, 6 and12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2019

Primary Completion (Actual)

July 7, 2019

Study Completion (Anticipated)

August 9, 2021

Study Registration Dates

First Submitted

July 25, 2020

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPER 3-3-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

one year

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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