Restoration of Carious Class v Anterior TeethNCT06950762
Aesthetic Performance of Two Injectable Resin Composites in Class V Cavities: A Randomized Clinical Trial
A study testing Giomer based injectable composite and Universal injectable resin composite in people with Restoration of Carious Class v Anterior Teeth, run by Future University in Egypt.
Trial summary
Using bioactive injectable resin composite in anterior class v carious lesions can provide better aesthetic outcome and marginal integrity by releasing multiple ions, including fluoride. This offers better marginal integrity due to presence of S-PRG fillers Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Restoration of Carious Class v Anterior Teeth
- What is being tested?
- Giomer based injectable composite and Universal injectable resin composite
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2025to 13 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-60 years.
- Co-operative participants approving to participate in the study.
- Male or female patients.
- Medically free participants.
- Moderate or high caries risk participants.
Who cannot join
- Systemic disease or severe medical complications.
- Participants with a history of allergy to any component of restorations will be used in the study.
- Lack of compliance
- Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits
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
Using bioactive injectable resin composite in anterior class v carious lesions can provide better aesthetic outcome and marginal integrity by releasing multiple ions, including fluoride. This offers better marginal integrity due to presence of S-PRG fillers
- Being tested
- Giomer based injectable composite, Universal injectable resin composite
- Keywords
- Giomer based injectable composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giomer based injectable compositeProcedure or surgery
Giomers utilize surface pre-reacted glass (SPRG) technology, which involves an acid-base reaction between fluorine-containing glass particles and polymer-containing acid when exposed to water. This reaction results in the formation of a glass ionomer phase, which is then dispersed throughout the resin. Furthermore, the S-PRG fillers present in giomer materials enable the continuous release and replenishment of fluoride, offering long-lasting protection against the recurrence of caries
Universal injectable resin compositeProcedure or surgery
Conventional injectable resin composite
| Study group | Role | What they receive |
|---|---|---|
| Beautifil flow plus x f00 | Active comparator | Bioactive giomer based injectable resin composite Receives: Procedure: Giomer based injectable composite |
| G-aenial universal injectable resin composite | Active comparator | conventional injectable resin composite Receives: Procedure: Universal injectable resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal discoloration using FDI criteria
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start10 Jun 2025 (estimated)
- Primary completion13 Apr 2026 (estimated)
- Study completion13 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restoration of Carious Class v Anterior TeethStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Elhariry, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950762
- Sponsor's protocol ID
- class v restoration
- Status last verified
- Jun 2025
- First submitted
- 12 Apr 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Performance of Two Injectable Resin Composites in Class V Cavities: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06950762
- Acronym / sponsor ID
- class v restoration
- Keywords
- Giomer based injectable composite
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 13 Apr 2026 (estimated)
- Study completion
- 13 Apr 2026 (estimated)
- First posted
- 30 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.
Using bioactive injectable resin composite in anterior class v carious lesions can provide better aesthetic outcome and marginal integrity by releasing multiple ions, including fluoride. This offers better marginal integrity due to presence of S-PRG fillers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beautifil flow plus x f00 | Active comparator | Procedure: Giomer based injectable compositeBioactive giomer based injectable resin composite |
| G-aenial universal injectable resin composite | Active comparator | Procedure: Universal injectable resin compositeconventional injectable resin composite |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 20-60 years.
- Co-operative participants approving to participate in the study.
- Male or female patients.
- Medically free participants.
- Moderate or high caries risk participants.
Key exclusion criteria (4 listed)
- Systemic disease or severe medical complications.
- Participants with a history of allergy to any component of restorations will be used in the study.
- Lack of compliance
- Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre 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 |
|---|---|---|
| Giomer based injectable compositeGiomers utilize surface pre-reacted glass (SPRG) technology, which involves an acid-base reaction between fluorine-containing glass particles and polymer-containing acid when exposed to water. This reaction results in the formation of a glass ionomer phase, which is then dispersed throughout the resin. Furthermore, the S-PRG fillers present in giomer materials enable the continuous release and replenishment of fluoride, offering long-lasting protection against the recurrence of caries | Procedure or surgery | Beautifil flow plus x f00 |
| Universal injectable resin compositeConventional injectable resin composite | Procedure or surgery | G-aenial universal injectable resin composite |
Primary outcome
Marginal discoloration using FDI criteria
Time frame: 12 Month
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 18 Jun 2025.
- Individual participant dataSharing planned: Yes
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 Giomer based injectable composite and Universal injectable resin composite in people with Restoration of Carious Class v Anterior Teeth, 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 5 inclusion and 4 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 18 Jun 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 Abdelrhman Ahmed Elhariry, BDS (+201069630412, abdelrhman.elhariry1998@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal discoloration using FDI criteria (time frame: 12 Month). 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 18 Jun 2025.