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

• ClinicalTrials.gov Identifier: NCT04701320
• Recruitment Status: Active, not recruiting
• First Posted: January 8, 2021
• Last Update Posted: January 8, 2021
• Sponsor: Cairo University
• Information provided by (Responsible Party): Reham nabil mahmoud, Cairo University

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?

Condition or disease	Intervention/treatment	Phase
Dental Restoration Failure	Drug: Conventional glass ionomer; Drug: Nano hydroxyapatite reinforced glass ionomer	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: July 7, 2019
• Actual Primary Completion Date: July 7, 2019
• Estimated Study Completion Date: August 9, 2021

Arms and Interventions

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 Name: 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 Name: Fujiix gc corporation

Outcome Measures

Primary Outcome Measures :

1. 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)

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Egypt

Faculty of dentistry

Cairo, Egypt, 002

Sponsors and Collaborators

Cairo University

More Information

• Responsible Party: Reham nabil mahmoud, associate lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT04701320
• Other Study ID Numbers: OPER 3-3-6
• First Posted: January 8, 2021
• Last Update Posted: January 8, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol
• Time Frame: one year

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Reham nabil mahmoud, Cairo University:

Glass Carbomer GCP glass fill root caries Clinical perfomance

Additional relevant MeSH terms:

Root Caries; Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Methamphetamine; Central Nervous System Stimulants; Physiological Effects of Drugs; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Uptake Inhibitors