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

NCT05624008 | Unknown DMC

• 1 other identifier: Bioceramic GIC
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Caries

Outcome Measures

Primary Outcomes (1)

• Change in Marginal adaptation score

  Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)

  Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (6)

• Change in Retention score

  Baseline, 3 months, 6 months, 12 months

• Change in Color match score

  Baseline, 3 months, 6 months, 12 months

• Change in Marginal discoloration score

  Baseline, 3 months, 6 months, 12 months

• Change in Secondary caries score

  Baseline, 3 months, 6 months, 12 months

• Change in Wear score

  Baseline, 3 months, 6 months, 12 months

Study Arms (2)

Bioceramic glass ionomer restoration

EXPERIMENTAL

Calcium aluminate modified glass ionomer

Other: Bioceramic glass ionomer restoration

Resin modified glass ionomer restoration

ACTIVE COMPARATOR

type II resin modified glass ionomer cement

Other: Resin modified glass ionomer restoration

Interventions

Bioceramic glass ionomer restoration OTHER

bioactive glass ionomer with unique biocompatibility and biological regenerative properties

Bioceramic glass ionomer restoration

Resin modified glass ionomer restoration OTHER

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

Resin modified glass ionomer restoration

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, ElManial, 11553, Egypt

RECRUITING

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree candidate, Conservative Dentistry Department, Faculty of Dentistry

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 21, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)