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.

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Caries
• Intervention / Treatment: Other: Bioceramic glass ionomer restoration; Other: Resin modified glass ionomer restoration

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • ElManial
    • Cairo, ElManial, Egypt, 11553
      • Recruiting
      • Faculty of Dentistry, Cairo University
      • Contact: Mariam Abdalnaieem; Phone Number: +201063712563; Email: mariam.abdalnaieem@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bioceramic glass ionomer restoration; Calcium aluminate modified glass ionomer	Other: Bioceramic glass ionomer restoration; bioactive glass ionomer with unique biocompatibility and biological regenerative properties
Active Comparator: Resin modified glass ionomer restoration; type II resin modified glass ionomer cement	Other: Resin modified glass ionomer restoration; A hybrid of glass ionomer and composite resin with acid-base and polymerizable components

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: November 5, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Root Caries; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: Bioceramic GIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No