Clinical Performance of Bioactive Bioceramic Glass Ionomer Restorations vs Conventional High Viscous Glass Ionomer Restorations in Geriatric Patients With Carious Cervical Lesions: A One Year Randomized Clinical Trial.

Cairo University1 site in 1 country28 target enrollmentJune 1, 2022

ConditionsCervical Caries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cervical Caries
Sponsor: Cairo University
Enrollment: 28
Locations: 1
Primary Endpoint: Change in Marginal adaptation score
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to clinically evaluate the performance of the bioceramic glass ionomer compared to conventional high viscosity glass ionomer for restoration of carious cervical lesions in geriatric patients over 12 months follow up.

Registry

clinicaltrials.gov

Start Date

June 1, 2022

End Date

February 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cairo University

Responsible Party

Principal Investigator

Mariam Mohammed Abd Al-Naieem

Master degree candidate, Conservative Dentistry Department, Faculty of Dentistry

Cairo University

Eligibility Criteria

Inclusion Criteria

•Geriatric patients aged above 55 years
•Patients with untreated carious lesions
•Patients who have at least 20 teeth under occlusion
•Patients with normal occlusion
•Vital teeth with carious cervical lesion with asymptomatic vital pulp.
•Teeth with no or minimum mobility.
•Teeth with normal occlusion.
•Teeth with surrounding healthy gingiva and supporting-structures.

Exclusion Criteria

•Patients who are unable to return for recall appointments
•Presence of abnormal oral, medical or mental conditions.
•Patients with severe medical diseases.
•Patients with xerostomia
•Patients with parafunctional habits.
•Non vital teeth.
•Teeth with signs or symptoms of pulpitis.
•Teeth with non carious lesions.

Outcomes

Primary Outcomes

Change in Marginal adaptation score

Time Frame: Baseline, 3 months, 6 months, 12 months

Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)

Secondary Outcomes

Change in Retention score(Baseline, 3 months, 6 months, 12 months)
Change in Color match score(Baseline, 3 months, 6 months, 12 months)
Change in Marginal discoloration score(Baseline, 3 months, 6 months, 12 months)
Change in Secondary caries score(Baseline, 3 months, 6 months, 12 months)
Change in Wear score(Baseline, 3 months, 6 months, 12 months)
Change in Postoperative hypersensitivity score(Baseline, 3 months, 6 months, 12 months)