Class V Dental RestorationsNCT07921407
Clinical and 3D Evaluation of Injectable Versus Conventional Composite in Class V Restorations
A study testing Packable, nano-hybrid composite in people with Class V Dental Restorations, run by Cairo University.
Trial summary
The study aims to clinically assess the surface finish and periodontal response of injectable resin composite vs conventional resin composite in class V restorations and reevaluate after six months follow u. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Class V Dental Restorations
- What is being tested?
- Packable, nano-hybrid composite
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2026to 15 Apr 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients presenting with Class V cervical cavities requiring restoration.
- Age range ( ≥18 years).
- Teeth with vital pulp.
- Patients with acceptable oral hygiene and willingness to participate and attend follow-up visits.
Who cannot join
- Patients with systemic diseases affecting periodontal health or healing.
- Poor oral hygiene or active periodontal disease.
- Non-vital teeth or teeth with periapical pathology.
- Severe parafunctional habits.
- Allergy to resin-based materials.
- Pregnant or lactating women.
About this study
Official title: Clinical Assessment and 3D Evaluation of Surface Properties and Periodontal Response of Injectable Bioactive Resin Composite Versus Conventional Resin Composite in Restoration of Class V Cavities: Randomized Clinical Trial
The study aims to clinically assess the surface finish and periodontal response of injectable resin composite vs conventional resin composite in class V restorations and reevaluate after six months follow u. It is aim to answer which composite has no change in periodontal response, superior marginal integrity surface texture. Researcher will compare the two composites, and the participants will have the restorations in class V and get a follow up after 6 months.
- Conditions
- Class V Dental Restorations
- Being tested
- Packable, nano-hybrid composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packable, nano-hybrid compositeDevice
Bioactive, injectable composite
| Study group | Role | What they receive |
|---|---|---|
| Packable nano-hybrid composite | Active comparator | Not described Receives: Device: Packable, nano-hybrid composite |
| Bioactive injectable composite | Experimental | Not described Receives: Device: Packable, nano-hybrid composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color change
Color change of the restorations will be clinically evaluated using FDI criteria by calibrated examiner.
Measured: At baseline after 3 months after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start25 Oct 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class V Dental RestorationsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Adnan M Aladah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921407
- Sponsor's protocol ID
- CONS-3-3-5
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment and 3D Evaluation of Surface Properties and Periodontal Response of Injectable Bioactive Resin Composite Versus Conventional Resin Composite in Restoration of Class V Cavities: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07921407
- Acronym / sponsor ID
- CONS-3-3-5
- Conditions
- Class V Dental Restorations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 6 Nov 2026 (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 study aims to clinically assess the surface finish and periodontal response of injectable resin composite vs conventional resin composite in class V restorations and reevaluate after six months follow u. It is aim to answer which composite has no change in periodontal response, superior marginal integrity surface texture. Researcher will compare the two composites, and the participants will have the restorations in class V and get a follow up after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Packable nano-hybrid composite | Active comparator | Device: Packable, nano-hybrid composite |
| Bioactive injectable composite | Experimental | Device: Packable, nano-hybrid composite |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients presenting with Class V cervical cavities requiring restoration.
- Age range ( ≥18 years).
- Teeth with vital pulp.
- Patients with acceptable oral hygiene and willingness to participate and attend follow-up visits.
Key exclusion criteria (6 listed)
- Patients with systemic diseases affecting periodontal health or healing.
- Poor oral hygiene or active periodontal disease.
- Non-vital teeth or teeth with periapical pathology.
- Severe parafunctional habits.
- Allergy to resin-based materials.
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 |
|---|---|---|
| Packable, nano-hybrid compositeBioactive, injectable composite | Device | Bioactive injectable composite, Packable nano-hybrid composite |
Primary outcome
Color change
Time frame: At baseline after 3 months after 6 months
Color change of the restorations will be clinically evaluated using FDI criteria by calibrated examiner.
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 6 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Packable, nano-hybrid composite in people with Class V Dental Restorations, 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 6 Nov 2026. 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?
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?
Color change (time frame: At baseline after 3 months after 6 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 6 Nov 2026.