Cervical CariesNCT06946134
18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial
A study testing FIT SA and Beautifil Flow Plus F00 in people with Cervical Caries, run by Cairo University.
Trial summary
The material under investigation will offer the patient a high strength and high durability restoration with the advantage of having anti-bacterial properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Caries
- What is being tested?
- FIT SA and Beautifil Flow Plus F00
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Feb 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical carious lesions in anterior teeth and premolars
- Small to moderate class V carious lesion (ICDAS 3 \& 4).
- Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth
Who cannot join
- Cervical carious lesions in molars.
- Deep carious defects (close to pulp, less than 1 mm distance).
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth, Fractured or cracked teeth.
- Endodontically treated teeth.
- Periodontally affected teeth
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 material under investigation will offer the patient a high strength and high durability restoration with the advantage of having anti-bacterial properties.
Read the detailed description
There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions.
- Conditions
- Cervical Caries
- Being tested
- FIT SA, Beautifil Flow Plus F00
- Keywords
- Self-adhesive giomer, Bioactive, Randomized clinical trial., USPHS criteria, Carious cervical lesion, Class V, Clinical performance, FIT SA, Beautifil Flow Plus
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT SAOther
self-adhesive flowable giomer restorative material
Beautifil Flow Plus F00Other
Conventional flowable giomer restorative material
| Study group | Role | What they receive |
|---|---|---|
| Beautifil Flow Plus F00 | Active comparator | Conventional flowable giomer restorative material Receives: Other: Beautifil Flow Plus F00 |
| FIT SA | Experimental | Self adhesive flowable giomer restorative material Receives: Other: FIT SA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance
Clinical Performance using Modified USPHS criteria
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study startSep 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amera Nabel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946134
- Sponsor's protocol ID
- CairoU PhD protocol for Amira
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06946134
- Acronym / sponsor ID
- CairoU PhD protocol for Amira
- Conditions
- Cervical Caries
- Keywords
- Self-adhesive giomer, Bioactive, Randomized clinical trial., USPHS criteria, Carious cervical lesion, Class V, Clinical performance, FIT SA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Apr 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 material under investigation will offer the patient a high strength and high durability restoration with the advantage of having anti-bacterial properties.
Detailed description
There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions.
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 |
|---|---|---|
| Beautifil Flow Plus F00 | Active comparator | Other: Beautifil Flow Plus F00Conventional flowable giomer restorative material |
| FIT SA | Experimental | Other: FIT SASelf adhesive flowable giomer restorative material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cervical carious lesions in anterior teeth and premolars
- Small to moderate class V carious lesion (ICDAS 3 \& 4).
- Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth
Key exclusion criteria (6 listed)
- Cervical carious lesions in molars.
- Deep carious defects (close to pulp, less than 1 mm distance).
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth, Fractured or cracked teeth.
- Endodontically treated teeth.
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 |
|---|---|---|
| FIT SAself-adhesive flowable giomer restorative material | Other | FIT SA |
| Beautifil Flow Plus F00Conventional flowable giomer restorative material | Other | Beautifil Flow Plus F00 |
Primary outcome
Clinical Performance
Time frame: 18 months
Clinical Performance using Modified USPHS criteria
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 27 Apr 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions
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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 FIT SA and Beautifil Flow Plus F00 in people with Cervical 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?
The sponsor lists 4 inclusion and 6 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 27 Apr 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 Amira Nabil El-Gaaly, PhD degree (00201099872098, amera.elgaaly@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Performance (time frame: 18 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 27 Apr 2025.