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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05624008
Enrollment
28
Registered
2022-11-21
Start date
2022-06-01
Completion date
2024-02-29
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Caries

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.

Interventions

OTHERBioceramic glass ionomer restoration

bioactive glass ionomer with unique biocompatibility and biological regenerative properties

OTHERResin modified glass ionomer restoration

A hybrid of glass ionomer and composite resin with acid-base and polymerizable components

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Marginal adaptation scoreBaseline, 3 months, 6 months, 12 monthsModified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)

Secondary

MeasureTime frameDescription
Change in Color match scoreBaseline, 3 months, 6 months, 12 monthsModified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Marginal discoloration scoreBaseline, 3 months, 6 months, 12 monthsModified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Retention scoreBaseline, 3 months, 6 months, 12 monthsModified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Wear scoreBaseline, 3 months, 6 months, 12 monthsModified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Postoperative hypersensitivity scoreBaseline, 3 months, 6 months, 12 monthsModified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Secondary caries scoreBaseline, 3 months, 6 months, 12 monthsModified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026