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

NCT ID: NCT05624008

Last Updated: 2022-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-02-29

Brief Summary

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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

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Conditions

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Cervical Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bioceramic glass ionomer restoration

Calcium aluminate modified glass ionomer

Group Type EXPERIMENTAL

Bioceramic glass ionomer restoration

Intervention Type OTHER

bioactive glass ionomer with unique biocompatibility and biological regenerative properties

Resin modified glass ionomer restoration

type II resin modified glass ionomer cement

Group Type ACTIVE_COMPARATOR

Resin modified glass ionomer restoration

Intervention Type OTHER

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

Interventions

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Bioceramic glass ionomer restoration

bioactive glass ionomer with unique biocompatibility and biological regenerative properties

Intervention Type OTHER

Resin modified glass ionomer restoration

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Mohammed Abd Al-Naieem

Master degree candidate, Conservative Dentistry Department, Faculty of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University

Cairo, ElManial, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Mariam Abdalnaieem

Role: primary

+201063712563

Other Identifiers

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Bioceramic GIC

Identifier Type: -

Identifier Source: org_study_id

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