Back to resultsClinical Performance of Bioceramic vs High Viscosity GIC for Cervical Restorations of Geriatric Patients
Primary Purpose
Cervical Caries
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bioceramic glass ionomer restoration
Resin modified glass ionomer restoration
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Caries
Eligibility Criteria
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.
Sites / Locations
- Faculty of Dentistry, Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bioceramic glass ionomer restoration
Resin modified glass ionomer restoration
Arm Description
Calcium aluminate modified glass ionomer
type II resin modified glass ionomer cement
Outcomes
Primary Outcome Measures
Change in Marginal adaptation score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Secondary Outcome Measures
Change in Retention score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Color match score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Marginal discoloration score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Secondary caries score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Wear score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Postoperative hypersensitivity score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05624008
Brief Title
Clinical Performance of Bioceramic vs High Viscosity GIC for Cervical Restorations of Geriatric Patients
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bioceramic glass ionomer restoration
Arm Type
Experimental
Arm Description
Calcium aluminate modified glass ionomer
Arm Title
Resin modified glass ionomer restoration
Arm Type
Active Comparator
Arm Description
type II resin modified glass ionomer cement
Intervention Type
Other
Intervention Name(s)
Bioceramic glass ionomer restoration
Intervention Description
bioactive glass ionomer with unique biocompatibility and biological regenerative properties
Intervention Type
Other
Intervention Name(s)
Resin modified glass ionomer restoration
Intervention Description
A hybrid of glass ionomer and composite resin with acid-base and polymerizable components
Primary Outcome Measure Information:
Title
Change in Marginal adaptation score
Description
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Time Frame
Baseline, 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change in Retention score
Description
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in Color match score
Description
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in Marginal discoloration score
Description
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in Secondary caries score
Description
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in Wear score
Description
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in Postoperative hypersensitivity score
Description
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Time Frame
Baseline, 3 months, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
State/Province
ElManial
ZIP/Postal Code
11553
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam Abdalnaieem
Phone
+201063712563
Email
mariam.abdalnaieem@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Performance of Bioceramic vs High Viscosity GIC for Cervical Restorations of Geriatric Patients
We'll reach out to this number within 24 hrs