Proximal Cavities of Posterior TeethEarly Phase 1NCT07457749
Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth
A Early Phase 1 study testing Stela, SDI, Australia and Beautifil II, Shofu, Japan in people with Proximal Cavities of Posterior Teeth, run by British University In Egypt at 1 site in Egypt.
Trial summary
The development of dental caries is multi-factorial mainly due to the presence of 4 elements which are: dental biofilm, fermentable carbohydrates , dental hard tissue and time. Other additional social and environmental factors can have a substantial impact on the onset and course of the disease. Read more about this study
- Who is it for?
- Ages 18 to 47 years
- Conditions the study is for
- Proximal Cavities of Posterior Teeth
- What is being tested?
- Stela, SDI, Australia and Beautifil II, Shofu, Japan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2026to 18 Mar 2028
- Phase
- Early Phase 1
- 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 47 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects between the ages of 18-47 years old
- Primary caries removal
- Good or moderate oral hygiene
- Free of periodontal diseases (probing depth and attachment levels within normal limits/ no furcation involvement/ no mobility)
- Cooperative patients who agree to keep the scheduled recall appointments for data collection and maintenance
Who cannot join
- Composite or amalgam removal
- Caries extended to the cemento-enamel junction in Class II caries
- Grade II or III mobility
- Considerable periodontal disease without treatment
- Endodontically treated teeth with extensive loss of tooth tissues
- Severe wear facets and/or parafunctional activities as clenching or nocturnal bruxism.
- Subjects who are pregnant during the duration of the study
- Subjects with high caries activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, The British University in Egypt
Cairo, El Sherouk City, 11837
Dalia Ghalwash Profressor Dr., +20 19283, Dalia.Ghalwash@bue.edu.eg
About this study
Official title: Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth: A 2-year Randomized Controlled Clinical Trial
The development of dental caries is multi-factorial mainly due to the presence of 4 elements which are: dental biofilm, fermentable carbohydrates , dental hard tissue and time. Other additional social and environmental factors can have a substantial impact on the onset and course of the disease. Dietary habits, oral hygiene, salivary flow and fluoride exposure are key factors that influence the susceptibility to dental caries. If dental caries is properly managed, it is a preventable and reversible disease. The proximal teeth surfaces are the most susceptible sites for demineralization from the acidic byproducts. In modern restorative dentistry, clinicians always seek solutions that streamline procedures, improve outcomes and reduce chair time for patients. Traditional light-cured composite systems often involve a complex seven step process which includes etching, priming, bonding and curing which consumes from 90 to 120 seconds to be completed. With each additional step, the risk of technique errors increases, potentially compromising the longevity of the restoration. Self-cure composites, with their simplified application process, are emerging as a preferred choice over the traditional seven-step composite materials. Recently, a novel self-cured high-performance bulk-fill restorative material has been introduced into the market (Stela, SDI, Victoria, Australia). It's particularly known for its "unlimited" depth of cure and self-adhesive properties.
- Conditions
- Proximal Cavities of Posterior Teeth
- Being tested
- Stela, SDI, Australia, Beautifil II, Shofu, Japan
- Keywords
- clinical performance, self-cured resin composite, bioactive, proximal cavities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stela, SDI, AustraliaDrug
Stela, (SDI ) is a novel self-cured bulkfill dental restorative material that is used in combination with an adhesive primer (Stela primer) which doesn't require light curing but it undergoes polymerization upon contact with the restorative material.
Beautifil II, Shofu, JapanDrug
Beautifil II is a light-cured bioactive nanohybrid resin composite restorative material. It is a renowned Giomer (Glass-ionomer/composite hybrid) restorative material from Shofu. It is famous for its "S-PRG" (Surface Pre-Reacted Glass) technology, which allows it to release and recharge fluoride like a glass ionomer while maintaining the aesthetics and durability of a composite.
| Study group | Role | What they receive |
|---|---|---|
| Beautifil II , Shofu (Light-cured Resin Composite) | Active comparator | It is a light-cured bioactive nanohybrid resin composite restorative material Receives: Drug: Beautifil II, Shofu, Japan |
| Stela, SDI, Australia (Self-cured Resin Composite) | Experimental | It is a novel self-cured bulk-fill restorative material. It is offered in two application forms (Stela Automix \& Stela Capsule) that is used in combination with a proprietary adhesive primer (Stela Primer), which does not require light curing, but it undergoes polymerization upon contact with the restorative material in addition to its ability to generate minimal shrinkage stresses. The polymerization starting at the bottom of the cavity helps drastically reduce polymerization shrinkage stress, which is a common cause of post-operative sensitivity. Receives: Drug: Stela, SDI, Australia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal contact tightness of examined class II restorations
This primary outcome will be measured using the FDI criteria for direct and indirect restorations
Measured: Baseline (after 1 week) and at 6, 12, 18, 24 months
Secondary outcomes (1)
Postoperative Hypersensitivity
One-week post-operative hypersensitivity will be examined using a visual analogue scale following the FDI criteria (absence/presence of hypersensitivity).
Measured: Immediate post procedure and after 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start18 Feb 2026
- Primary completion18 Feb 2028 (estimated)
- Study completion18 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Cavities of Posterior 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SARA SAWAF, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457749
- Sponsor's protocol ID
- 25-069
- Other IDs
- Self-funded
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth: A 2-year Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07457749
- Acronym / sponsor ID
- 25-069
- Conditions
- Proximal Cavities of Posterior Teeth
- Keywords
- clinical performance, self-cured resin composite, bioactive, proximal cavities
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 18 Feb 2028 (estimated)
- Study completion
- 18 Mar 2028 (estimated)
- First posted
- 9 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.
The development of dental caries is multi-factorial mainly due to the presence of 4 elements which are: dental biofilm, fermentable carbohydrates , dental hard tissue and time. Other additional social and environmental factors can have a substantial impact on the onset and course of the disease. Dietary habits, oral hygiene, salivary flow and fluoride exposure are key factors that influence the susceptibility to dental caries. If dental caries is properly managed, it is a preventable and reversible disease. The proximal teeth surfaces are the most susceptible sites for demineralization from the acidic byproducts. In modern restorative dentistry, clinicians always seek solutions that streamline procedures, improve outcomes and reduce chair time for patients. Traditional light-cured composite systems often involve a complex seven step process which includes etching, priming, bonding and curing which consumes from 90 to 120 seconds to be completed. With each additional step, the risk of technique errors increases, potentially compromising the longevity of the restoration. Self-cure composites, with their simplified application process, are emerging as a preferred choice over the traditional seven-step composite materials. Recently, a novel self-cured high-performance bulk-fill restorative material has been introduced into the market (Stela, SDI, Victoria, Australia). It's particularly known for its "unlimited" depth of cure and self-adhesive properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beautifil II , Shofu (Light-cured Resin Composite) | Active comparator | Drug: Beautifil II, Shofu, JapanIt is a light-cured bioactive nanohybrid resin composite restorative material |
| Stela, SDI, Australia (Self-cured Resin Composite) | Experimental | Drug: Stela, SDI, AustraliaIt is a novel self-cured bulk-fill restorative material. It is offered in two application forms (Stela Automix \& Stela Capsule) that is used in combination with a proprietary adhesive primer (Stela Primer), which does not require light curing, but it undergoes polymerization upon contact with the restorative material in addition to its ability to generate minimal shrinkage stresses. The polymerization starting at the bottom of the cavity helps drastically reduce polymerization shrinkage stress, which is a common cause of post-operative sensitivity. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects between the ages of 18-47 years old
- Primary caries removal
- Good or moderate oral hygiene
- Free of periodontal diseases (probing depth and attachment levels within normal limits/ no furcation involvement/ no mobility)
- Cooperative patients who agree to keep the scheduled recall appointments for data collection and maintenance
Key exclusion criteria (8 listed)
- Composite or amalgam removal
- Caries extended to the cemento-enamel junction in Class II caries
- Grade II or III mobility
- Considerable periodontal disease without treatment
- Endodontically treated teeth with extensive loss of tooth tissues
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 |
|---|---|---|
| Stela, SDI, AustraliaStela, (SDI ) is a novel self-cured bulkfill dental restorative material that is used in combination with an adhesive primer (Stela primer) which doesn't require light curing but it undergoes polymerization upon contact with the restorative material. | Drug | Stela, SDI, Australia (Self-cured Resin Composite) |
| Beautifil II, Shofu, JapanBeautifil II is a light-cured bioactive nanohybrid resin composite restorative material. It is a renowned Giomer (Glass-ionomer/composite hybrid) restorative material from Shofu. It is famous for its "S-PRG" (Surface Pre-Reacted Glass) technology, which allows it to release and recharge fluoride like a glass ionomer while maintaining the aesthetics and durability of a composite. | Drug | Beautifil II , Shofu (Light-cured Resin Composite) |
Primary outcome
Proximal contact tightness of examined class II restorations
Time frame: Baseline (after 1 week) and at 6, 12, 18, 24 months
This primary outcome will be measured using the FDI criteria for direct and indirect restorations
1 secondary outcome
Postoperative Hypersensitivity
Time frame: Immediate post procedure and after 1 week
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 19 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Proximal Cavities of Posterior Teeth
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Performance of Reinforced 3D-Printed Versus Direct Bulk-Filled Resin Composites for Restoring Extensive Class II Cavities in Vital Molars
Class II Lesions, 3D Printing
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Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite
Proximal Cavities of Posterior Teeth
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Stela, SDI, Australia and Beautifil II, Shofu, Japan in people with Proximal Cavities of Posterior Teeth, 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal contact tightness of examined class II restorations (time frame: Baseline (after 1 week) and at 6, 12, 18, 24 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 19 Mar 2026.