Class II Dental RestorationsFSC-HPC-GCNCT07334509
Clinical Evaluation of a Simplified-Shade Nano-Hybrid Composite With Full-Coverage Silane Coating and High-Performance Pulverized Fillers
A study testing Simplified Nano hybrid composite and Conventional, multi shade nano, hybrid composite in people with Class II Dental Restorations, run by Cairo University.
Trial summary
The goal of this clinical trial is to evaluate simplified, shade, non-hybrid composite versus conventional multi Shade nano hybrid composite in class two restorations and reevaluate after one year follow up It's aim to answer Which composite has superior, anatomic form, color, match marginal, integrity, postoperative… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Dental Restorations
- What is being tested?
- Simplified Nano hybrid composite and Conventional, multi shade nano, hybrid composite
- Type of treatment
- 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
- 15 Jan 2026to 15 Jan 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
- healthy human
- age ranging from18-64 years with a class two posterior restoration
- a fairly good oral hygiene
- teeth should be indicated for direct composite restoration
- teeth with vital pulp no symptoms of irreversible pulpitis
- patient who are willing to follow up after 12 months
- patient who have signed the informed consent
Who cannot join
- people under 18 years old or over 64 years old
- people with disabilities
- people with bad oral hygiene
- patient with systematic disease that could be affecting oral health
- cavities reaching the pulp
- people with periodontal diseases
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- patient with parafunctional habits such as bruxism
- patient who are allergic to the restoration
- patients who are unwilling to follow after 12 months
About this study
Official title: Clinical Evaluation of a Simplified-Shade Nano-Hybrid Composite With Full-Coverage Silane Coating and High-Performance Pulverized Fillers Versus Conventional Multi-Shade Nano- Hybrid Composite in Direct Restoration of Posterior Proximal Carious Lesions After a 12- Month Follow-Up Period Using USPHS Criteria: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to evaluate simplified, shade, non-hybrid composite versus conventional multi Shade nano hybrid composite in class two restorations and reevaluate after one year follow up It's aim to answer Which composite has superior, anatomic form, color, match marginal, integrity, postoperative sensitivity, surface texture, and recurrent caries Researcher will compare the two composites And the participants will Have the restorations in posterior teeth and get a follow up after 12 months
- Conditions
- Class II Dental Restorations
- Being tested
- Simplified Nano hybrid composite, Conventional, multi shade nano, hybrid composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified Nano hybrid compositeDevice
It's a simplified shade system for dental composite that is nano hybrid with full coverage saline coating and high performance pulverized fillers
Conventional, multi shade nano, hybrid compositeDevice
Traditional, multi shaded nano, hybrid, composite risen
| Study group | Role | What they receive |
|---|---|---|
| conventional multi shaded nano hybrid composite | Active comparator | This group will receive the conventional multi shaded nano hybrid composite Receives: Device: Conventional, multi shade nano, hybrid composite |
| shaded nano hybrid composite | Experimental | Participants receive the simplified shaded nano hybrid composite restoration Receives: Device: Simplified Nano hybrid composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation assessed using modified USPHS criteria
Marginal adaptation of the restorations will be clinically evaluated using the Modified United States Public Health Service (USPHS) criteria by a calibrated examiner.
The scoring system includes the following categories:
- Alpha (Score = 1): Excellent marginal adaptation, no visible gap
- Bravo (Score = 2): Clinically acceptable marginal discrepancy
- Charlie (Score = 3): Clinically unacceptable marginal defect requiring replacement
The minimum score is 1 (best outcome) and the maximum score is 3 (worst outcome).
Lower scores indicate better marginal adaptation, while higher scores indicate poorer marginal adaptation.
Measured: At baseline after six months after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II 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
- 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, Raoh Kareem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334509
- Sponsor's protocol ID
- CONS-3-7-5
- Acronym
- FSC-HPC-GC
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 12 Jan 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Simplified-Shade Nano-Hybrid Composite With Full-Coverage Silane Coating and High-Performance Pulverized Fillers Versus Conventional Multi-Shade Nano- Hybrid Composite in Direct Restoration of Posterior Proximal Carious Lesions After a 12- Month Follow-Up Period Using USPHS Criteria: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07334509
- Acronym / sponsor ID
- FSC-HPC-GC / CONS-3-7-5
- Conditions
- Class II Dental Restorations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 12 Jan 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 goal of this clinical trial is to evaluate simplified, shade, non-hybrid composite versus conventional multi Shade nano hybrid composite in class two restorations and reevaluate after one year follow up It's aim to answer Which composite has superior, anatomic form, color, match marginal, integrity, postoperative sensitivity, surface texture, and recurrent caries Researcher will compare the two composites And the participants will Have the restorations in posterior teeth and get a follow up after 12 months
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 |
|---|---|---|
| conventional multi shaded nano hybrid composite | Active comparator | Device: Conventional, multi shade nano, hybrid compositeThis group will receive the conventional multi shaded nano hybrid composite |
| shaded nano hybrid composite | Experimental | Device: Simplified Nano hybrid compositeParticipants receive the simplified shaded nano hybrid composite restoration |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- healthy human
- age ranging from18-64 years with a class two posterior restoration
- a fairly good oral hygiene
- teeth should be indicated for direct composite restoration
- teeth with vital pulp no symptoms of irreversible pulpitis
Key exclusion criteria (9 listed)
- people under 18 years old or over 64 years old
- people with disabilities
- people with bad oral hygiene
- patient with systematic disease that could be affecting oral health
- cavities reaching the pulp
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 |
|---|---|---|
| Simplified Nano hybrid compositeIt's a simplified shade system for dental composite that is nano hybrid with full coverage saline coating and high performance pulverized fillers | Device | shaded nano hybrid composite |
| Conventional, multi shade nano, hybrid compositeTraditional, multi shaded nano, hybrid, composite risen | Device | conventional multi shaded nano hybrid composite |
Primary outcome
Marginal adaptation assessed using modified USPHS criteria
Time frame: At baseline after six months after 1 year
Marginal adaptation of the restorations will be clinically evaluated using the Modified United States Public Health Service (USPHS) criteria by a calibrated examiner. The scoring system includes the following categories: * Alpha (Score = 1): Excellent marginal adaptation, no visible gap * Bravo (Score = 2): Clinically acceptable marginal discrepancy * Charlie (Score = 3): Clinically unacceptable marginal defect requiring replacement The minimum score is 1 (best outcome) and the maximum score is 3 (worst outcome). Lower scores indicate better marginal adaptation, while higher scores indicate poorer marginal adaptation.
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 12 Jan 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 Simplified Nano hybrid composite and Conventional, multi shade nano, hybrid composite in people with Class II 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 7 inclusion and 9 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 12 Jan 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?
Marginal adaptation assessed using modified USPHS criteria (time frame: At baseline after six months after 1 year). 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 12 Jan 2026.