Deep CariesNCT06882343
Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations
A study testing Beautiful Flow Plus X and Dentsply Nanohybrid flowable composite in people with Deep Caries and Caries, Dental, run by Future University in Egypt.
Trial summary
The goal of this study is to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer Shofu Flow Plus X F03 compared to nanohybrid resin composite restoration in deep subgingival proximal cavities over a period of 12 months. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Deep Caries, Caries, Dental
- What is being tested?
- Beautiful Flow Plus X and Dentsply Nanohybrid 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
- 1 Apr 2025to 1 Apr 2026
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults patients (20-50)
- Good oral hygiene (plaque index 0 or 1 )
- Patient approving to participate in the study
- Absence of parafunctional habits and/or bruxism
Who cannot join
- Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
- Bad oral hygiene (plaque index 2 or 3 )
- Heavy smokers
- Patients undergoing or will start orthodontic treatment
- Patients with removable prothesis
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
Official title: Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations: a Randomized Clinical Trial
The goal of this study is to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer Shofu Flow Plus X F03 compared to nanohybrid resin composite restoration in deep subgingival proximal cavities over a period of 12 months.
- Conditions
- Deep Caries, Caries, Dental
- Being tested
- Beautiful Flow Plus X, Dentsply Nanohybrid 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.
Beautiful Flow Plus XOther
Shofu's Beautifil Flow Plus X F03 is an advanced injectable bioactive composite that merges the adaptability of flowable composites with the mechanical properties of hybrid composites
Dentsply Nanohybrid flowable compositeOther
a conventional nano hybrid flowable composite
| Study group | Role | What they receive |
|---|---|---|
| Bioactive Giomer Material | Active comparator | Not described Receives: Other: Beautiful Flow Plus X |
| Nanohybrid resin composite | Active comparator | Not described Receives: Other: Dentsply Nanohybrid flowable composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent caries
- Yes: no evidence of caries continuous along the margin
- No: caries evident continuous with the margin of restoration
Measured: 1 week, 6 months and 12 months
Secondary outcomes (3)
Post-operative sensitivity
- No: Absent
- Yes: Present
Measured: 1 week, 6 months and 12 months
Fracture of the restoration
- Restoration is intact and fully retained.
- Restoration is partially retained with some portion of the restoration still intact.
- Restoration is completely missing
Measured: 1 week, 6 months and 12 months
Bleeding on probing
- 0 Healthy gums
- 1 Bleeding on probing
- 2 periodontal problem with bone loss
Measured: 1 week, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Hossam Elmoaty, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882343
- Sponsor's protocol ID
- Ahmed elmoety protocol
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06882343
- Acronym / sponsor ID
- Ahmed elmoety protocol
- Conditions
- Deep Caries, Caries, Dental
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 18 Mar 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 goal of this study is to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer Shofu Flow Plus X F03 compared to nanohybrid resin composite restoration in deep subgingival proximal cavities over a period of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive Giomer Material | Active comparator | Other: Beautiful Flow Plus X |
| Nanohybrid resin composite | Active comparator | Other: Dentsply Nanohybrid flowable composite |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults patients (20-50)
- Good oral hygiene (plaque index 0 or 1 )
- Patient approving to participate in the study
- Absence of parafunctional habits and/or bruxism
Key exclusion criteria (7 listed)
- Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
- Bad oral hygiene (plaque index 2 or 3 )
- Heavy smokers
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 |
|---|---|---|
| Beautiful Flow Plus XShofu's Beautifil Flow Plus X F03 is an advanced injectable bioactive composite that merges the adaptability of flowable composites with the mechanical properties of hybrid composites | Other | Bioactive Giomer Material |
| Dentsply Nanohybrid flowable compositea conventional nano hybrid flowable composite | Other | Nanohybrid resin composite |
Primary outcome
Recurrent caries
Time frame: 1 week, 6 months and 12 months
* Yes: no evidence of caries continuous along the margin * No: caries evident continuous with the margin of restoration
3 secondary outcomes
Post-operative sensitivity
Time frame: 1 week, 6 months and 12 months
Fracture of the restoration
Time frame: 1 week, 6 months and 12 months
Bleeding on probing
Time frame: 1 week, 6 months and 12 months
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 21 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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 study testing Beautiful Flow Plus X and Dentsply Nanohybrid flowable composite in people with Deep Caries and Caries, Dental, run by Future University 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 21 Mar 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.
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 Ahmed Elmoaty, Dentist (+201555717662, ahmedelmoety96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent caries (time frame: 1 week, 6 months and 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 Mar 2025.