Carious Cervical LesionsNCT07576673
Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT
A study testing Class V Restoration - Polofil and Class V Restoration - Stela in people with Carious Cervical Lesions, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to compare and evaluate the clinical performance of a self cure composite system versus a highly filled flowable composite in the restoration of carious cervical lesions over an 18 months follow up period. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Carious Cervical Lesions
- What is being tested?
- Class V Restoration - Polofil and Class V Restoration - Stela
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2026to 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Patient-related Criteria:
- Inclusion Criteria:
- Patients consulting in the outpatient clinic with cervical carious lesion.
- Age between 21-45 years.
- Males and females.
- Exclusion Criteria:
- Systemic disease or severe medical complication.
- Allergy to any of the restorative materials.
- Pregnancy.
- Disabilities.
- Heavy smoking; xerostomia.
- Lack of compliance.
- Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits.
Tooth-related Criteria:
- Inclusion Criteria:
- Small to moderate class V carious lesion.
- Teeth are vital with no signs of irreversible pulpitis.
- Caries cervical margins above the CEJ.
- Well-formed and fully erupted in normal functional occlusion with natural antagonist.
- Exclusion Criteria:
- Deciduous teeth; as the study is targeting only permanent teeth.
- Deep carious defects (close to the pulp, less than 1 mm distance).
- Tooth hypersensitivity.
- Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
- Heavy occlusion and occlusal contacts or history of bruxism.
- Endodontically treated teeth.
- Periapical pathology or signs of pulpal pathology.
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
Faculty of Dentistry, Cairo University
Cairo
Abdelrahman Hamza, Bachelor of Science, +20 1063330630, abdelrahmanh.hamza@dentistry.cu.edu.eg
About this study
Official title: Clinical Performance of a Self-Cure Composite System Versus a Highly Filled Flowable Composite System in Carious Cervical Lesions: A Randomized 18 Months Clinical Trial
The aim of the study is to compare and evaluate the clinical performance of a self cure composite system versus a highly filled flowable composite in the restoration of carious cervical lesions over an 18 months follow up period.
Read the detailed description
Examination and selection of patients will be done according to the inclusion and exclusion criteria. A class V cavity will be prepared after local anesthesia has been given. Followed by the placement of the restorative material according to the randomization sequence.
For the intervention: the primer will be applied first followed by filling of the cavity using self cure composite (Stella Automix or Stela Capsule, SDI Ltd, Australia). For the control group: etching of the cavity (Kulzer Gluma Etch, Kulzer GmbH, Germany) will be done followed by rinsing, drying, applying the bonding agent (Solobond M, Voco GmbH, Germany), curing, and lastly, applying the highly filled flowable composite (Polofil NHT flow, Voco Gmbh, Germany) and curing.
- Conditions
- Carious Cervical Lesions
- Being tested
- Class V Restoration - Polofil, Class V Restoration - Stela
- Keywords
- Class V, Cervical Carious Lesions, Self-cure Composite, Highly Filled Flowable Composite, Stela
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Class V Restoration - PolofilProcedure or surgery
A class V cavity with 1 mm occlusal bevel will be prepared after administering local anesthesia. Rubber dam isolation will be done, , etching of the enamel (20-30 seconds) and dentin (15 seconds) using a 35% phosphoric acid etch (Kulzer Gluma Etch, Kulzer GmbH, Germany), then rinsing for 20 seconds followed by controlled drying of the cavity till it's slightly moist. Application of the bonding agent (Solobond M, Voco GmbH, Germany) using a disposable brush and leaving it to act for 30 seconds then an air jet will be used to disperse the bonding agent. Curing for 20 seconds will be done using a LED light curing unit with curing intensity 1200-3000 mw/cm2 (CuringPen-E, Changzhou Sifary Medical Technology Co., Ltd, China). Flowable composite (Polofil NHT flow, Voco GmbH, Germany) will be placed, adapted by gold plated applicator then light polymerized for 20 seconds using light emitting diode (LED) light curing unit.
Class V Restoration - StelaProcedure or surgery
A class V cavity with 1 mm occlusal bevel will be prepared after administrating local anesthesia followed by rubber dam isolation. Stela Primer (SDI Limited, Australia.) will be applied for 5 seconds on the cavity and the margins, then it will be gently dried with air for 2-3 seconds without light curing. The self-cure bulk fill resin composite (Stela Automix or Stela Capsule, SDI Limited, Australia) will be applied then sculpted using a gold-plated composite applicator (Lascod, Italy). Full polymerization will take place after 4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Self-cure Bulk Fill Resin Composite (Stela Automix or Stela Capsule, SDI Limited, Australia) | Experimental | Not described Receives: Procedure: Class V Restoration - Stela |
| Highly Filled Flowable Composite (Polofil NHT flow, Voco GmbH, Germany) | Active comparator | Not described Receives: Procedure: Class V Restoration - Polofil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
The restoration will be clinically assessed according to the modified USPHS criteria. Restoration will be given Alpha score when there is no loss of restoration. It will be given a Charlie score when there is loss of restoration and need for replacement.
Measured: 18 Months
Secondary outcomes (6)
Marginal Adaptation
The restoration will be clinically assessed according to the modified USPHS criteria. It will be give an Alpha score when the restoration is closely adapted with no detectable margin. It will be given a Bravo score when there is a detectable marginal discrepancy, but it still clinically acceptable. It will be given a Charlie score when there is a marginal crevice that is clinically unacceptable.
Measured: 18 months
Marginal Discoloration
The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no discoloration between the tooth and the restoration. It will be given a Bravo score when there is superficial discoloration which can be polished away. It will be give a Charlie score when the discoloration has penetrated beyond the margin in pulpal direction.
Measured: 18 months
Post-operative Sensitivity
The restoration will be clinically assessed according to the modified USPHS criteria. It will be give an Alpha score when there is no post-operative sensitivity and a Charlie score when there is post-operative sensitivity.
Measured: 18 months
Recurrent Caries
The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no detectable recurrent caries and a Charlie score when recurrent caries is detected.
Measured: 18 months
Surface Roughness
The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no surface defect. It will be given a bravo score when there is minimal surface defect. It will be given a charlie score when there is a severe surface defect.
Measured: 18 months
Color Match
The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when the restoration matches the color of the tooth. It will be give a Bravo score when there is an acceptable mismatch. It will be given a Charlie score when there is an unacceptable mismatch.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious Cervical LesionsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Hamza Halim Hamza, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576673
- Sponsor's protocol ID
- Self-cure Bulk fill Resin
- Status last verified
- Jul 2026
- First submitted
- 1 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Self-Cure Composite System Versus a Highly Filled Flowable Composite System in Carious Cervical Lesions: A Randomized 18 Months Clinical Trial
- ClinicalTrials.gov ID
- NCT07576673
- Acronym / sponsor ID
- Self-cure Bulk fill Resin
- Conditions
- Carious Cervical Lesions
- Keywords
- Class V, Cervical Carious Lesions, Self-cure Composite, Highly Filled Flowable Composite, Stela
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 May 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 aim of the study is to compare and evaluate the clinical performance of a self cure composite system versus a highly filled flowable composite in the restoration of carious cervical lesions over an 18 months follow up period.
Detailed description
Examination and selection of patients will be done according to the inclusion and exclusion criteria. A class V cavity will be prepared after local anesthesia has been given. Followed by the placement of the restorative material according to the randomization sequence.
For the intervention: the primer will be applied first followed by filling of the cavity using self cure composite (Stella Automix or Stela Capsule, SDI Ltd, Australia). For the control group: etching of the cavity (Kulzer Gluma Etch, Kulzer GmbH, Germany) will be done followed by rinsing, drying, applying the bonding agent (Solobond M, Voco GmbH, Germany), curing, and lastly, applying the highly filled flowable composite (Polofil NHT flow, Voco Gmbh, Germany) and curing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-cure Bulk Fill Resin Composite (Stela Automix or Stela Capsule, SDI Limited, Australia) | Experimental | Procedure: Class V Restoration - Stela |
| Highly Filled Flowable Composite (Polofil NHT flow, Voco GmbH, Germany) | Active comparator | Procedure: Class V Restoration - Polofil |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 V Restoration - PolofilA class V cavity with 1 mm occlusal bevel will be prepared after administering local anesthesia. Rubber dam isolation will be done, , etching of the enamel (20-30 seconds) and dentin (15 seconds) using a 35% phosphoric acid etch (Kulzer Gluma Etch, Kulzer GmbH, Germany), then rinsing for 20 seconds followed by controlled drying of the cavity till it's slightly moist. Application of the bonding agent (Solobond M, Voco GmbH, Germany) using a disposable brush and leaving it to act for 30 seconds then an air jet will be used to disperse the bonding agent. Curing for 20 seconds will be done using a LED light curing unit with curing intensity 1200-3000 mw/cm2 (CuringPen-E, Changzhou Sifary Medical Technology Co., Ltd, China). Flowable composite (Polofil NHT flow, Voco GmbH, Germany) will be placed, adapted by gold plated applicator then light polymerized for 20 seconds using light emitting diode (LED) light curing unit. | Procedure or surgery | Highly Filled Flowable Composite (Polofil NHT flow, Voco GmbH, Germany) |
| Class V Restoration - StelaA class V cavity with 1 mm occlusal bevel will be prepared after administrating local anesthesia followed by rubber dam isolation. Stela Primer (SDI Limited, Australia.) will be applied for 5 seconds on the cavity and the margins, then it will be gently dried with air for 2-3 seconds without light curing. The self-cure bulk fill resin composite (Stela Automix or Stela Capsule, SDI Limited, Australia) will be applied then sculpted using a gold-plated composite applicator (Lascod, Italy). Full polymerization will take place after 4 minutes. | Procedure or surgery | Self-cure Bulk Fill Resin Composite (Stela Automix or Stela Capsule, SDI Limited, Australia) |
Primary outcome
Retention
Time frame: 18 Months
The restoration will be clinically assessed according to the modified USPHS criteria. Restoration will be given Alpha score when there is no loss of restoration. It will be given a Charlie score when there is loss of restoration and need for replacement.
6 secondary outcomes
Marginal Adaptation
Time frame: 18 months
Marginal Discoloration
Time frame: 18 months
Post-operative Sensitivity
Time frame: 18 months
Recurrent Caries
Time frame: 18 months
Surface Roughness
Time frame: 18 months
Color Match
Time frame: 18 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 6 Jul 2026.
- 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 V Restoration - Polofil and Class V Restoration - Stela in people with Carious Cervical Lesions, 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?
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 Jul 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?
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 Abdelrahman Hamza, Bachelor of Science (+20 1063330630, abdelrahmanh.hamza@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 18 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 Jul 2026.