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

Phase 1

• Conditions: Dental Restoration Failure
• Interventions: Drug: Conventional glass ionomer; Drug: Nano hydroxyapatite reinforced glass ionomer

• Registration Number: NCT04701320
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2019-07-07
• Primary Completion: 2019-07-07
• Study First Submitted: 2020-07-25
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-06
• Last Update Submitted: 2021-01-06
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-08
• Study Completion: 2021-08-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fuji ix	Conventional glass ionomer	Conventional Glass Ionomer cement fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics, a wear resistant, self-adhesive
Glass carbomer	Nano hydroxyapatite reinforced glass ionomer	Nano hydroxyapatite Reinforced Glass Ionomer that results in chemical bond formation with tooth structure mimic that of enamel tissue

Primary Outcome Measures

Name	Time	Method
Clinical restorative performance Service (USHPS)	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)

Trial Locations

Locations (1)

Faculty of dentistry; 🇪🇬 Cairo, Egypt