Composite RestorationNCT07480070
Two-Year Clinical Performance of Self-Cured Resin Composite in Comparison to Light-Cured Bioactive Resin Composite in Restoring Occlusal Cavities of Posterior Teeth.
A study testing Self Cured Composite and Bioactive Nano-hybrid composite in people with Composite Restoration, run by British University In Egypt at 1 site in Egypt.
Trial summary
Introduction: Resin composite restorations are among the most commonly used materials for restoring posterior teeth due to their aesthetic and mechanical properties. Self-cured resin composites have emerged as a promising option to overcome some of the limitations of conventional light-cured composites. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Composite Restoration
- What is being tested?
- Self Cured Composite and Bioactive Nano-hybrid composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients typically between 18 to 50 years old.
- Males or Females.
- Co-operative patients approving the trial.
- Good oral hygiene.
Who cannot join
- Lack of compliance.
- Patients with bad oral hygiene.
- Patients who are allergic to any ingredients used in the study.
- Medically compromised patients with systemic complications that would alter the treatment.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-Year Clinical Performance of Self-Cured Resin Composite in Comparison to Light-Cured Bioactive Resin Composite in Restoring Occlusal Cavities of Posterior Teeth. (A Randomized Controlled Clinical Trial)
Introduction: Resin composite restorations are among the most commonly used materials for restoring posterior teeth due to their aesthetic and mechanical properties. Self-cured resin composites have emerged as a promising option to overcome some of the limitations of conventional light-cured composites.
Aim: The aim of this study is to evaluate the effect of self-cured resin composite in restoring occlusal cavities of posterior teeth over a period of two years. The results will contribute to clarifying its efficiency and safety as a treatment option in daily clinical practice.
Read more
Research Steps: Fifty affected teeth will be selected and randomly allocated into groups.
Group (A): Self-cured resin composite group - self-cured resin composite will be used.
Group (B): Bioactive nano-hybrid resin composite group - bioactive nano-hybrid resin composite will be used.
The restorations will be evaluated after placement.
Introduction:
Resin composite restorations are among the most widely used materials in restorative dentistry due to their favorable aesthetic and physical properties. However, the success of these restorations largely depends on the type of material used and the technique of application. Conventional light-cured composites are the most common option, yet they may present certain limitations in cases where adequate isolation is difficult to achieve or in posterior areas of the mouth.
In contrast, self-cured resin composites have emerged as a promising alternative because of their ability to polymerize chemically without the need for a light source. These materials are characterized by ease of use and the possibility of application under limited clinical conditions, making them suitable in certain clinical situations.
Aim of the Study:
The aim of this randomized controlled clinical trial is to evaluate the clinical performance of a newly introduced self-cured resin composite (Stela, SDI, Australia) in class I occlusal cavities of posterior teeth compared to light-cured Nano-hybrid bioactive resin composite (Beautifill II, Shofu, Japan) regarding functional properties over a follow-up of 2 years.
Research Question:
Does the clinical performance of self-cured resin composite restorations differ from light cured nano-hybrid bioactive resin composite in class I cavities?
- Conditions
- Composite Restoration
- Being tested
- Self Cured Composite, Bioactive Nano-hybrid composite
- Keywords
- Class I cavities, Clinical Performance, FDI criteria, Self cured resin composite, Occlusal cavities, Two-Year, Light cured resin composite, Bioactive resin composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Cured CompositeProcedure or surgery
After cavity disinfection, the adhesive protocol system will be applied on the cavity and margins according to the manufacturer instructions using Stela primer then stela composite will be applied in single increment covering the margins. A period of 4 minutes is required till complete setting before starting finishing and polishing procedures
Bioactive Nano-hybrid compositeProcedure or surgery
After cavity disinfection, Selective etching of enamel will be done using 37% phosphoric acid etch on all enamel margins after protection of dentin for 20 seconds followed by rinsing and dryness. Then, a universal adhesive will be applied using micro brush on all cavity (Enamel and Dentin). A gentle air blast will be done for the adhesive for 5 seconds then cured for 20 seconds according to the manufacturer instructions. A thin layer (1mm) of highly filled flowable composite will be applied on the cavity floor and distributed using the tip of the explorer then cured for 20 seconds according to the manufacturer instructions. Finally, nano hybrid composite will be packed incrementally following the tooth anatomy and each increment will be cured for 20 seconds according to the manufacturer instructions.
For both groups sequential finishing and polishing will be done using red and yellow coded finishing stones, polishing tips and polishing paste according to the manufacturer instructions.
| Study group | Role | What they receive |
|---|---|---|
| Bioactive Nano-hybrid composite group | Active comparator | Not described Receives: Procedure: Bioactive Nano-hybrid composite |
| Self-cured composite group | Experimental | Not described Receives: Procedure: Self Cured Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional properties as assisted by FDI criteria for direct restorations
Unit of measurement is numbers and percentages
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Jan 2026
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Composite RestorationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ISRAA FOAD, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480070
- Sponsor's protocol ID
- 25-068
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 18 Mar 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Year Clinical Performance of Self-Cured Resin Composite in Comparison to Light-Cured Bioactive Resin Composite in Restoring Occlusal Cavities of Posterior Teeth. (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07480070
- Acronym / sponsor ID
- 25-068
- Conditions
- Composite Restoration
- Keywords
- Class I cavities, Clinical Performance, FDI criteria, Self cured resin composite, Occlusal cavities, Two-Year, Light cured resin composite, Bioactive resin composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 18 Mar 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.
Introduction: Resin composite restorations are among the most commonly used materials for restoring posterior teeth due to their aesthetic and mechanical properties. Self-cured resin composites have emerged as a promising option to overcome some of the limitations of conventional light-cured composites.
Aim: The aim of this study is to evaluate the effect of self-cured resin composite in restoring occlusal cavities of posterior teeth over a period of two years. The results will contribute to clarifying its efficiency and safety as a treatment option in daily clinical practice.
Research Steps: Fifty affected teeth will be selected and randomly allocated into groups.
Group (A): Self-cured resin composite group - self-cured resin composite will be used.
Group (B): Bioactive nano-hybrid resin composite group - bioactive nano-hybrid resin composite will be used.
The restorations will be evaluated after placement.
Introduction:
Resin composite restorations are among the most widely used materials in restorative dentistry due to their favorable aesthetic and physical properties. However, the success of these restorations largely depends on the type of material used and the technique of application. Conventional light-cured composites are the most common option, yet they may present certain limitations in cases where adequate isolation is difficult to achieve or in posterior areas of the mouth.
In contrast, self-cured resin composites have emerged as a promising alternative because of their ability to polymerize chemically without the need for a light source. These materials are characterized by ease of use and the possibility of application under limited clinical conditions, making them suitable in certain clinical situations.
Aim of the Study:
The aim of this randomized controlled clinical trial is to evaluate the clinical performance of a newly introduced self-cured resin composite (Stela, SDI, Australia) in class I occlusal cavities of posterior teeth compared to light-cured Nano-hybrid bioactive resin composite (Beautifill II, Shofu, Japan) regarding functional properties over a follow-up of 2 years.
Research Question:
Does the clinical performance of self-cured resin composite restorations differ from light cured nano-hybrid bioactive resin composite in class I cavities?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive Nano-hybrid composite group | Active comparator | Procedure: Bioactive Nano-hybrid composite |
| Self-cured composite group | Experimental | Procedure: Self Cured Composite |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients typically between 18 to 50 years old.
- Males or Females.
- Co-operative patients approving the trial.
- Good oral hygiene.
Key exclusion criteria (5 listed)
- Lack of compliance.
- Patients with bad oral hygiene.
- Patients who are allergic to any ingredients used in the study.
- Medically compromised patients with systemic complications that would alter the treatment.
- Inability to give informed consent.
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 |
|---|---|---|
| Self Cured CompositeAfter cavity disinfection, the adhesive protocol system will be applied on the cavity and margins according to the manufacturer instructions using Stela primer then stela composite will be applied in single increment covering the margins. A period of 4 minutes is required till complete setting before starting finishing and polishing procedures | Procedure or surgery | Self-cured composite group |
| Bioactive Nano-hybrid compositeAfter cavity disinfection, Selective etching of enamel will be done using 37% phosphoric acid etch on all enamel margins after protection of dentin for 20 seconds followed by rinsing and dryness. Then, a universal adhesive will be applied using micro brush on all cavity (Enamel and Dentin). A gentle air blast will be done for the adhesive for 5 seconds then cured for 20 seconds according to the manufacturer instructions. A thin layer (1mm) of highly filled flowable composite will be applied on the cavity floor and distributed using the tip of the explorer then cured for 20 seconds according to the manufacturer instructions. Finally, nano hybrid composite will be packed incrementally following the tooth anatomy and each increment will be cured for 20 seconds according to the manufacturer instructions. For both groups sequential finishing and polishing will be done using red and yellow coded finishing stones, polishing tips and polishing paste according to the manufacturer instructions. | Procedure or surgery | Bioactive Nano-hybrid composite group |
Primary outcome
Functional properties as assisted by FDI criteria for direct restorations
Time frame: 2 years
Unit of measurement is numbers and percentages
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Cured Composite and Bioactive Nano-hybrid composite in people with Composite Restoration, run by British University In Egypt at 1 site 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 5 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional properties as assisted by FDI criteria for direct restorations (time frame: 2 years). 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 Mar 2026.