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

Not Applicable

Recruiting

• Conditions: Cervical Caries
• Interventions: Other: Resin modified glass ionomer restoration; Other: Bioceramic glass ionomer restoration

• Registration Number: NCT05624008
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-05
• Study First Submitted QC: 2022-11-13
• Last Update Submitted: 2022-11-13
• Study First Posted: 2022-11-21
• Last Update Posted: 2022-11-21
• Primary Completion: 2023-12
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resin modified glass ionomer restoration	Resin modified glass ionomer restoration	type II resin modified glass ionomer cement
Bioceramic glass ionomer restoration	Bioceramic glass ionomer restoration	Calcium aluminate modified glass ionomer

Primary Outcome Measures

Name	Time	Method
Change in Marginal adaptation score	Baseline, 3 months, 6 months, 12 months	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)

Secondary Outcome Measures

Name	Time	Method
Change in Color match score	Baseline, 3 months, 6 months, 12 months	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Wear score	Baseline, 3 months, 6 months, 12 months	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Retention score	Baseline, 3 months, 6 months, 12 months	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Marginal discoloration score	Baseline, 3 months, 6 months, 12 months	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Secondary caries score	Baseline, 3 months, 6 months, 12 months	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Postoperative hypersensitivity score	Baseline, 3 months, 6 months, 12 months	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, ElManial, Egypt