Dental CariesEarly Phase 1NCT06790511
Clinical Performance of Bioactive Highly Filled Injectable Flowable Composite for Direct Posterior Occlusal Conservative Restorations Using FDI Criteria: Two Year Randomized Clinical Trial
A Early Phase 1 study testing bioactive highly filled injectable flowable composite and highly filled injectable flowable composite in people with Dental Caries, run by Cairo University.
Trial summary
The aim of this study is to evaluate Clinical Performance of bioactive highly filled injectable flowable composite for direct posterior occlusal conservative restorations using FDI Criteria Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- bioactive highly filled injectable flowable composite and highly filled injectable flowable composite
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 1 Jan 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 16 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria:The inclusion criteria: patient age range from 16-45 years, with a premolar indicated for extraction, patients required at least a couple of Class I restorations. The patient should have good general health.
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Exclusion Criteria:Where the exclusion criteria will be: poor oral hygiene, sever or chronic periodontal disease or bruxism, severe tooth sensitivity, non-vital or fracture or cracked teeth, defective restorations or bleaching procedures during the last 6 months, pregnancy, and/or lactation, and allergy to the main components of the products to be used in the study.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to evaluate Clinical Performance of bioactive highly filled injectable flowable composite for direct posterior occlusal conservative restorations using FDI Criteria
- Conditions
- Dental Caries
- Being tested
- bioactive highly filled injectable flowable composite, highly filled injectable flowable composite
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioactive highly filled injectable flowable compositeOther
Also called Shofou Flow Plus X
bioactive highly filled injectable flowable composite
highly filled injectable flowable compositeOther
Also called GC G-ænial Universal Flo
highly filled injectable flowable composite
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Other: highly filled injectable flowable composite |
| Intervention | Experimental | Not described Receives: Other: bioactive highly filled injectable flowable composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of caries
Restorations will be assessed for recurrence of caries by visual examination, short air drying
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sherif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790511
- Sponsor's protocol ID
- Mohamed Sherif PHD
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Bioactive Highly Filled Injectable Flowable Composite for Direct Posterior Occlusal Conservative Restorations Using FDI Criteria: Two Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06790511
- Acronym / sponsor ID
- Mohamed Sherif PHD
- Conditions
- Dental Caries
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 24 Jan 2025 (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 evaluate Clinical Performance of bioactive highly filled injectable flowable composite for direct posterior occlusal conservative restorations using FDI Criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: highly filled injectable flowable composite |
| Intervention | Experimental | Other: bioactive highly filled injectable flowable composite |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| bioactive highly filled injectable flowable compositeAlso: Shofou Flow Plus Xbioactive highly filled injectable flowable composite | Other | Intervention |
| highly filled injectable flowable compositeAlso: GC G-ænial Universal Flohighly filled injectable flowable composite | Other | Control Group |
Primary outcome
Recurrence of caries
Time frame: 24 Months
Restorations will be assessed for recurrence of caries by visual examination, short air drying
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing bioactive highly filled injectable flowable composite and highly filled injectable flowable composite in people with Dental Caries, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Sherif ElAshmawy (+201112759933, mohamed.sherif@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of caries (time frame: 24 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 24 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.