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

Primary Purpose

Dental Restoration Failure

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Conventional glass ionomer
Nano hydroxyapatite reinforced glass ionomer
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Restoration Failure focused on measuring Glass Carbomer GCP glass fill root caries Clinical perfomance

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glass carbomer

Fuji ix

Arm Description

Nano hydroxyapatite Reinforced Glass Ionomer that results in chemical bond formation with tooth structure mimic that of enamel tissue

Conventional Glass Ionomer cement fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics, a wear resistant, self-adhesive

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
July 25, 2020
Last Updated
January 6, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04701320
Brief Title
Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer in Treatment of Root Caries in Geriatric Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2019 (Actual)
Primary Completion Date
July 7, 2019 (Actual)
Study Completion Date
August 9, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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?
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Restoration Failure
Keywords
Glass Carbomer GCP glass fill root caries Clinical perfomance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glass carbomer
Arm Type
Experimental
Arm Description
Nano hydroxyapatite Reinforced Glass Ionomer that results in chemical bond formation with tooth structure mimic that of enamel tissue
Arm Title
Fuji ix
Arm Type
Active Comparator
Arm Description
Conventional Glass Ionomer cement fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics, a wear resistant, self-adhesive
Intervention Type
Drug
Intervention Name(s)
Conventional glass ionomer
Other Intervention Name(s)
Fujiix gc corporation
Intervention Description
Conventional glass ionomer with enhanced mechanical and esthetic proberties
Intervention Type
Drug
Intervention Name(s)
Nano hydroxyapatite reinforced glass ionomer
Other Intervention Name(s)
Glass carbomer
Intervention Description
Nanohydroxyapatite reinforced glass ionomer restorative material with enhanced mechanical proberties and chemical adhesion to tooth structure
Primary Outcome Measure Information:
Title
Clinical restorative performance Service (USHPS)
Description
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)
Time Frame
Change from the baseline at 3, 6 and12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of dentistry
City
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
one year

Learn more about this trial

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

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