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

NCT04701320 | Unknown Phase 1 DMC

• 1 other identifier: OPER 3-3-6
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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?

Conditions

Dental Restoration Failure

Keywords

Glass Carbomer GCP glass fill root caries Clinical perfomance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Glass carbomer

EXPERIMENTAL

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

Fuji ix

ACTIVE COMPARATOR

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

Interventions

Conventional glass ionomer DRUG

Conventional glass ionomer with enhanced mechanical and esthetic proberties

Also known as: Fujiix gc corporation

Fuji ix

Nano hydroxyapatite reinforced glass ionomer DRUG

Nanohydroxyapatite reinforced glass ionomer restorative material with enhanced mechanical proberties and chemical adhesion to tooth structure

Also known as: Glass carbomer

Glass carbomer

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 50 years old
• Males or females.
• Community-dwelling
• Have five or more of their own teeth
• With ≥ 1 root caries lesion

You may not qualify if:

• Patients younger than 50 years old
• Disabilities.
• Systemic diseases or severe medically compromised.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry

Cairo, 002, Egypt

Location

MeSH Terms

Interventions

glass carbomer cement

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate lecturer

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: January 8, 2021
• Study Start: July 7, 2019
• Primary Completion: July 7, 2019
• Study Completion: August 9, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year

Locations

EG (1)