Clinical Performance of Bioceramic vs High Viscosity GIC for Cervical Restorations of Geriatric Patients

Cervical Caries Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05624008
• Other study ID #: Bioceramic GIC
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: February 2024

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Caries
• Root Caries

Intervention

Other:
• Bioceramic glass ionomer restoration
bioactive glass ionomer with unique biocompatibility and biological regenerative properties
• Resin modified glass ionomer restoration
A hybrid of glass ionomer and composite resin with acid-base and polymerizable components

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo	ElManial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Marginal adaptation score	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)	Baseline, 3 months, 6 months, 12 months
Secondary	Change in Retention score	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)	Baseline, 3 months, 6 months, 12 months
Secondary	Change in Color match score	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)	Baseline, 3 months, 6 months, 12 months
Secondary	Change in Marginal discoloration score	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)	Baseline, 3 months, 6 months, 12 months
Secondary	Change in Secondary caries score	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)	Baseline, 3 months, 6 months, 12 months
Secondary	Change in Wear score	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)	Baseline, 3 months, 6 months, 12 months
Secondary	Change in Postoperative hypersensitivity score	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)	Baseline, 3 months, 6 months, 12 months