Cervical CariesNCT06185881
Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)
A study testing restoration of cervical carious teeth in people with Cervical Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This research proposal is introduced to clinically test short fiber reinforced glass ionomer material from GC Europe due to gap of knowledge present in this area. It is characterized by higher flexural strength compared to resin modified glass ionomer (RMGIC). Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Caries
- What is being tested?
- restoration of cervical carious teeth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 28 Dec 2023
- 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 18 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with untreated cervical carious lesions
- 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.
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- Severe periodontal problems.
- Non carious cervical lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations Versus Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)
This research proposal is introduced to clinically test short fiber reinforced glass ionomer material from GC Europe due to gap of knowledge present in this area. It is characterized by higher flexural strength compared to resin modified glass ionomer (RMGIC). Additionally, the short fibers provided effective toughening of the RMGIC matrix by a fiber bridging mechanism.
- Conditions
- Cervical Caries
- Being tested
- restoration of cervical carious teeth
- Keywords
- fiber reinforced glass ionomer
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restoration of cervical carious teethProcedure or surgery
restoration of carious cervical lesions by glass ionomer
| Study group | Role | What they receive |
|---|---|---|
| Short fiber reinforced resin modified glass ionomer restorations (GC Europe) | Experimental | Not described Receives: Procedure: restoration of cervical carious teeth |
| Resin modified glass ionomer restoration. (Fugi II LC, GC Europe) | Active comparator | Not described Receives: Procedure: restoration of cervical carious teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Marginal integrity score
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Measured: [Time Frame: Baseline, 6 months, 12 months]
Secondary outcomes (3)
Change in Marginal discoloration, Color match, Gross fracture scores
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Measured: [Time Frame: Baseline, 6 months, 12 months]
Change in Secondary caries scores
Modified USPHS criteria with Alpha and Charlie scores (Categorical)
Measured: [Time Frame: Baseline, 6 months, 12 months]
Change in Post operative Hypersensitivity
Modified USPHS criteria with Alpha and Charlie scores (Categorical)
Measured: [Time Frame: Baseline, 7 days, 6 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Mar 2022
- Primary completion1 Apr 2023
- Study completion28 Dec 2023
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
- Single group
- Model description
- split mouth
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawda Hesham Abd ElAziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185881
- Sponsor's protocol ID
- CEBD 5/2022
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2023
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations Versus Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06185881
- Acronym / sponsor ID
- CEBD 5/2022
- Conditions
- Cervical Caries
- Keywords
- fiber reinforced glass ionomer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 29 Dec 2023 (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.
This research proposal is introduced to clinically test short fiber reinforced glass ionomer material from GC Europe due to gap of knowledge present in this area. It is characterized by higher flexural strength compared to resin modified glass ionomer (RMGIC). Additionally, the short fibers provided effective toughening of the RMGIC matrix by a fiber bridging mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- split mouth
| Arm | Type | Receives |
|---|---|---|
| Short fiber reinforced resin modified glass ionomer restorations (GC Europe) | Experimental | Procedure: restoration of cervical carious teeth |
| Resin modified glass ionomer restoration. (Fugi II LC, GC Europe) | Active comparator | Procedure: restoration of cervical carious teeth |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with untreated cervical carious lesions
- Patients with normal occlusion
- Vital teeth with carious cervical lesion with asymptomatic vital pulp.
- Teeth with no or minimum mobility.
- Teeth with normal occlusion.
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 |
|---|---|---|
| restoration of cervical carious teethrestoration of carious cervical lesions by glass ionomer | Procedure or surgery | Resin modified glass ionomer restoration. (Fugi II LC, GC Europe), Short fiber reinforced resin modified glass ionomer restorations (GC Europe) |
Primary outcome
Change in Marginal integrity score
Time frame: [Time Frame: Baseline, 6 months, 12 months]
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
3 secondary outcomes
Change in Marginal discoloration, Color match, Gross fracture scores
Time frame: [Time Frame: Baseline, 6 months, 12 months]
Change in Secondary caries scores
Time frame: [Time Frame: Baseline, 6 months, 12 months]
Change in Post operative Hypersensitivity
Time frame: [Time Frame: Baseline, 7 days, 6 months]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restoration of cervical carious teeth 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 6 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: finished, as of the sponsor's last update on 20 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Marginal integrity score (time frame: [Time Frame: Baseline, 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 20 Feb 2024.