Proximal Cavities of Posterior TeethNCT06859086
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
A study testing class II restoration in people with Proximal Cavities of Posterior Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study is To evaluate and compare the clinical performance of Self- Cure Bulk fill Composite Resin Versus Conventional Bulk fill resin composite in Restoration of Proximal Lesions over a Period of 24 months Follow-up. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Proximal Cavities of Posterior Teeth
- What is being tested?
- class II restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2025to May 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients consulting in one of the outpatient clinics listed above.
- Able to tolerate necessary restorative procedures.
- Provide informed consent.
- Accepts the 18 months follow-up period.
- Teeth with primary proximal carious lesions.
- Teeth are vital according to pulp-sensitivity tests.
- Well-formed and fully-erupted in normal functional occlusion with natural antagonist and adjacent teeth.
Who cannot join
- Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
- Pregnant women; as radiographs cannot be taken for them.
- Allergy to any of the restorative materials, including anesthetics.
- Uncooperative patients, will not abide by the instructions or attend the appointments.
- Tooth related criteria:
- Deciduous teeth; as the study is targeting only permanent teeth.
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- Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
- Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests), which would indicate irreversible pulpal damage.
- Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion, which would indicate pulp necrosis.
- Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.
- Teeth with cervical caries; which can't be evaluated on periapical radiographs.
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
Cairo University
Cairo
Wafaa Marei Kakat, Master, 00201554054804, wafaa.marei@dentistry.cu.edu.eg
About this study
Official title: Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite in Restoration of Proximal Lesions Over a Period Of 24 Months Follow-Up: A Randomized Clinical Trial
the aim of this study is To evaluate and compare the clinical performance of Self- Cure Bulk fill Composite Resin Versus Conventional Bulk fill resin composite in Restoration of Proximal Lesions over a Period of 24 months Follow-up.
Read the detailed description
Examination and selection of all patients will be done according to inclusion and exclusion criteria. A class II cavity will be prepared after local anesthesia has been given as required. Sectional matricing and wedging will be done.Followed by, placement of restorative material according to the randomization sequence.
For the intervention: The sectional matrix will be applied first, followed by filling of cavity with Self-Cure bulk-fill Resin Composite. (Stela Automix or Stela Capsule, SDI Ltd, Australia) For the control group: The sectional matrix will be applied first, followed by filling of the cavity with the bulk-fill resin composite material (Tetric N-Ceram Bulk Fill, Liechtenstein). Clinical evaluation will be done using USPHS criteria at 6,12,18 and 24 monthes follow up
- Conditions
- Proximal Cavities of Posterior Teeth
- Being tested
- class II restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
class II restorationProcedure or surgery
A class II cavity will be prepared after local anesthesia has been given as requierd . Rubber dam isolation will be done. Sectional matricing and wedging will be done. Followed by placement of restorative material according to the randomization sequence.
| Study group | Role | What they receive |
|---|---|---|
| Self- Cure Bulk fill Resin Composite (Stela Automix or Stela Capsule, SDI Ltd, Australia) | Experimental | New (Stela, SDI Ltd, Australia) restorative Self-cure: using the stela primer then stela composite with no curing. Receives: Procedure: class II restoration |
| Bulk-fill Resin Composite. (Tetric N-Ceram Bulk Fill, Liechtenstein) | Active comparator | After selective etching of enamel and bonding, the bulk-fill composite resins are inserted then curing. Receives: Procedure: class II restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation
The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.
Measured: 24 months
Secondary outcomes (8)
Marginal discoloration
The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.
Measured: 24 months
Recurrent caries
The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement.
Measured: 24 months
Retention analysis
The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement.
Measured: 24 months
Surface roughness
The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.
Measured: 24 months
Postoperative sensitivity
The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement.
Measured: 24 months
Anatomic form
The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.
Measured: 24 months
Proximal contact
The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.
Measured: 24 months
Color match
The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Marei Kakat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859086
- Sponsor's protocol ID
- SELF- CURE BULK-FILL RESIN
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite in Restoration of Proximal Lesions Over a Period Of 24 Months Follow-Up: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06859086
- Acronym / sponsor ID
- SELF- CURE BULK-FILL RESIN
- Conditions
- Proximal Cavities of Posterior Teeth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Mar 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.
the aim of this study is To evaluate and compare the clinical performance of Self- Cure Bulk fill Composite Resin Versus Conventional Bulk fill resin composite in Restoration of Proximal Lesions over a Period of 24 months Follow-up.
Detailed description
Examination and selection of all patients will be done according to inclusion and exclusion criteria. A class II cavity will be prepared after local anesthesia has been given as required. Sectional matricing and wedging will be done.Followed by, placement of restorative material according to the randomization sequence.
For the intervention: The sectional matrix will be applied first, followed by filling of cavity with Self-Cure bulk-fill Resin Composite. (Stela Automix or Stela Capsule, SDI Ltd, Australia) For the control group: The sectional matrix will be applied first, followed by filling of the cavity with the bulk-fill resin composite material (Tetric N-Ceram Bulk Fill, Liechtenstein). Clinical evaluation will be done using USPHS criteria at 6,12,18 and 24 monthes follow up
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 |
|---|---|---|
| Self- Cure Bulk fill Resin Composite (Stela Automix or Stela Capsule, SDI Ltd, Australia) | Experimental | Procedure: class II restorationNew (Stela, SDI Ltd, Australia) restorative Self-cure: using the stela primer then stela composite with no curing. |
| Bulk-fill Resin Composite. (Tetric N-Ceram Bulk Fill, Liechtenstein) | Active comparator | Procedure: class II restorationAfter selective etching of enamel and bonding, the bulk-fill composite resins are inserted then curing. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients consulting in one of the outpatient clinics listed above.
- Able to tolerate necessary restorative procedures.
- Provide informed consent.
- Accepts the 18 months follow-up period.
- Teeth with primary proximal carious lesions.
Key exclusion criteria (11 listed)
- Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
- Pregnant women; as radiographs cannot be taken for them.
- Allergy to any of the restorative materials, including anesthetics.
- Uncooperative patients, will not abide by the instructions or attend the appointments.
- Deciduous teeth; as the study is targeting only permanent teeth.
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 |
|---|---|---|
| class II restorationA class II cavity will be prepared after local anesthesia has been given as requierd . Rubber dam isolation will be done. Sectional matricing and wedging will be done. Followed by placement of restorative material according to the randomization sequence. | Procedure or surgery | Bulk-fill Resin Composite. (Tetric N-Ceram Bulk Fill, Liechtenstein), Self- Cure Bulk fill Resin Composite (Stela Automix or Stela Capsule, SDI Ltd, Australia) |
Primary outcome
Marginal adaptation
Time frame: 24 months
The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.
8 secondary outcomes
Marginal discoloration
Time frame: 24 months
Recurrent caries
Time frame: 24 months
Retention analysis
Time frame: 24 months
Surface roughness
Time frame: 24 months
Postoperative sensitivity
Time frame: 24 months
Anatomic form
Time frame: 24 months
Proximal contact
Time frame: 24 months
Color match
Time frame: 24 months
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 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing class II restoration in people with Proximal Cavities of Posterior Teeth, run by Cairo University 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 7 inclusion and 11 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 5 Mar 2025. 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?
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 Wafaa Marei Kakat, Master Degree (00201554054804, wafaa.marei@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal adaptation (time frame: 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 5 Mar 2025.