Occlusal CariesNCT06260644
Evaluation of Using Self-adhering Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial)
A study testing VertiseTM flowable composite (Kerr,USA) in people with Occlusal Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This research proposal is evaluating the clinical performance of using self-adhering flowable resin composite in repairing old occlusal defective resin composite versus conventional flowable resin composite restoration over 18 months. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Occlusal Caries
- What is being tested?
- VertiseTM flowable composite (Kerr,USA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to Oct 2025
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients (18-35 y)
- patients with defective resin composite class I restorations that need repair.
- dental motivated patients who attends regularly.
- Vital posterior teeth with repairable defective resin composite class I restorations.
- Localized marginal defect or marginal staining FDI 3\& 4.
- Teeth with no or minimum mobility \& healthy peridontium.
- No history of any irreversible pulpal pain or necrosis in the teeth to be restored.
Who cannot join
- • Patients with defective restorations that dictate replacement
- Uncooperative behavior limits the isolation techniques throughout the procedure.
- Presence of parafunctional habits.
- Patient with history of systemic medical disease, or any other serious relevant problem.
- High caries risk patients. Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
- Fractured or visibly cracked teeth.
- Symptoms of any pulp pathosis.
- Defective resin composite restorations that dictate replacement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Using Self-adhering Flowable Resin Composite Versus Conventional Nano-filled Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial)
This research proposal is evaluating the clinical performance of using self-adhering flowable resin composite in repairing old occlusal defective resin composite versus conventional flowable resin composite restoration over 18 months.
- Conditions
- Occlusal Caries
- Being tested
- VertiseTM flowable composite (Kerr,USA)
- Keywords
- flowable resin composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VertiseTM flowable composite (Kerr,USA)Procedure or surgery
self adhesive flowable resin composite restoration.
| Study group | Role | What they receive |
|---|---|---|
| Conventional flowable nano filled resin composite | Active comparator | Repairing the old defective class I composite restoration by conventional nano filled flowable resin composite. Receives: Procedure: VertiseTM flowable composite (Kerr,USA) |
| Self adhesive flowable resin composite | Experimental | Repairing the old defective class I composite restoration by self adhering flowable resin composite. Receives: Procedure: VertiseTM flowable composite (Kerr,USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration clinical performance using FDI criteria
FDI criteria mechanical parameters
Measured: assessment will be done after the treatment then 6 months, 12 months and18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Feb 2024
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusal 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
- Model description
- parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soha Sayed Hosny, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260644
- Sponsor's protocol ID
- Repairing defective composite
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 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 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Using Self-adhering Flowable Resin Composite Versus Conventional Nano-filled Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06260644
- Acronym / sponsor ID
- Repairing defective composite
- Conditions
- Occlusal Caries
- Keywords
- flowable resin composite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 15 Feb 2024 (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 evaluating the clinical performance of using self-adhering flowable resin composite in repairing old occlusal defective resin composite versus conventional flowable resin composite restoration over 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Conventional flowable nano filled resin composite | Active comparator | Procedure: VertiseTM flowable composite (Kerr,USA)Repairing the old defective class I composite restoration by conventional nano filled flowable resin composite. |
| Self adhesive flowable resin composite | Experimental | Procedure: VertiseTM flowable composite (Kerr,USA)Repairing the old defective class I composite restoration by self adhering flowable resin composite. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients (18-35 y)
- patients with defective resin composite class I restorations that need repair.
- dental motivated patients who attends regularly.
- Vital posterior teeth with repairable defective resin composite class I restorations.
- Localized marginal defect or marginal staining FDI 3\& 4.
Key exclusion criteria (8 listed)
- • Patients with defective restorations that dictate replacement
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 |
|---|---|---|
| VertiseTM flowable composite (Kerr,USA)self adhesive flowable resin composite restoration. | Procedure or surgery | Conventional flowable nano filled resin composite, Self adhesive flowable resin composite |
Primary outcome
Restoration clinical performance using FDI criteria
Time frame: assessment will be done after the treatment then 6 months, 12 months and18 months.
FDI criteria mechanical parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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 VertiseTM flowable composite (Kerr,USA) in people with Occlusal 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 7 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 15 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?
Results are not available in the source record.
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?
Restoration clinical performance using FDI criteria (time frame: assessment will be done after the treatment then 6 months, 12 months and18 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 15 Feb 2024.