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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05624008
Other study ID # Bioceramic GIC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT06185881 - Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial) N/A