Cervical CariesNCT05624008
Clinical Performance of Bioceramic vs High Viscosity GIC for Cervical Restorations of Geriatric Patients
A study testing Bioceramic glass ionomer restoration and Resin modified glass ionomer restoration in people with Cervical Caries, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Cervical Caries
- What is being tested?
- Bioceramic glass ionomer restoration and Resin modified glass ionomer restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, ElManial, 11553
Mariam Abdalnaieem, +201063712563, mariam.abdalnaieem@dentistry.cu.edu.eg
About this study
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.
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
- Being tested
- Bioceramic glass ionomer restoration, Resin modified glass ionomer restoration
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioceramic glass ionomer restorationOther
bioactive glass ionomer with unique biocompatibility and biological regenerative properties
Resin modified glass ionomer restorationOther
A hybrid of glass ionomer and composite resin with acid-base and polymerizable components
| Study group | Role | What they receive |
|---|---|---|
| Bioceramic glass ionomer restoration | Experimental | Calcium aluminate modified glass ionomer Receives: Other: Bioceramic glass ionomer restoration |
| Resin modified glass ionomer restoration | Active comparator | type II resin modified glass ionomer cement Receives: Other: Resin modified glass ionomer restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Marginal adaptation score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Measured: Baseline, 3 months, 6 months, 12 months
Secondary outcomes (6)
Change in Retention score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Measured: Baseline, 3 months, 6 months, 12 months
Change in Color match score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Measured: Baseline, 3 months, 6 months, 12 months
Change in Marginal discoloration score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Measured: Baseline, 3 months, 6 months, 12 months
Change in Secondary caries score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Measured: Baseline, 3 months, 6 months, 12 months
Change in Wear score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Measured: Baseline, 3 months, 6 months, 12 months
Change in Postoperative hypersensitivity score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start1 Jun 2022
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohammed Abd Al-Naieem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624008
- Sponsor's protocol ID
- Bioceramic GIC
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05624008
- Acronym / sponsor ID
- Bioceramic GIC
- Conditions
- Cervical Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioceramic glass ionomer restoration | Experimental | Other: Bioceramic glass ionomer restorationCalcium aluminate modified glass ionomer |
| Resin modified glass ionomer restoration | Active comparator | Other: Resin modified glass ionomer restorationtype II resin modified glass ionomer cement |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioceramic glass ionomer restorationbioactive glass ionomer with unique biocompatibility and biological regenerative properties | Other | Bioceramic glass ionomer restoration |
| Resin modified glass ionomer restorationA hybrid of glass ionomer and composite resin with acid-base and polymerizable components | Other | Resin modified glass ionomer restoration |
Primary outcome
Change in Marginal adaptation score
Time frame: Baseline, 3 months, 6 months, 12 months
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
6 secondary outcomes
Change in Retention score
Time frame: Baseline, 3 months, 6 months, 12 months
Change in Color match score
Time frame: Baseline, 3 months, 6 months, 12 months
Change in Marginal discoloration score
Time frame: Baseline, 3 months, 6 months, 12 months
Change in Secondary caries score
Time frame: Baseline, 3 months, 6 months, 12 months
Change in Wear score
Time frame: Baseline, 3 months, 6 months, 12 months
Change in Postoperative hypersensitivity score
Time frame: Baseline, 3 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty of Dentistry, Cairo University
Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioceramic glass ionomer restoration and Resin modified glass ionomer restoration in people with Cervical Caries, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Marginal adaptation score (time frame: Baseline, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.