Class II Dental CariesNCT06120868
Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites
A study testing Surefil one® and Filtek One in people with Class II Dental Caries, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
This study aimed to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring class II cavities. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Class II Dental Caries
- What is being tested?
- Surefil one® and Filtek One
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2022to 1 Sep 2023
- 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
- Patients in need of restorative treatment on at least two class II Cavities in premolars or molars.
- Presence of proximal caries in digital x-ray with code 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS I).
- Presence of proximal caries in initial or moderate stage according to the International Caries Classification and Management System (ICCMS™).
- Only posterior teeth with class II cavities that have antagonistic contact and at least one proximal contact.
- Absence of parafunctional habits.
- Good general health
Who cannot join
- Serious medical disorders
- Clinical signs of bruxism, traumatic malocclusion
- Pregnant or breast feeding at the time of restoration placement
- Intolerance or allergy toward the applied restorative materials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites (a Randomized Controlled Clinical Study)
This study aimed to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring class II cavities.
- Conditions
- Class II Dental Caries
- Being tested
- Surefil one®, Filtek One
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surefil one®Other
For Surefil one® restorations, the capsule will be activated by pressing it against a stable surface, then mixed in a capsule mixer for 10 s. The capsule tip will be inserted into the proximal box, and the material is extruded as the tip is gradually moved in a coronal direction, ensuring that the material adapts to the cavity bottom and walls.
Filtek OneOther
Scotchbond™ Universal (SBU) will be used as an adhesive system in self-etch mode for FiltekTM One restoration. SBU will be applied actively for 20 seconds with a disposable brush tip, air-dried gently for 5 seconds to create a consistent bond thickness, then light-cured for 10 seconds. The FiltekTM One will be packed in increments up to 4 mm thick. A second layer of FiltekTM One will be applied on top of the first 4-mm layer if 4 mm is not adequate to properly restore the tooth. Each increment will be light cured for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Surefil one Self-adhesive bulk fill restorative (SABF) | Experimental | Not described Receives: Other: Surefil one® |
| Filtek One Bulk Fill (FOBF) | Active comparator | Not described Receives: Other: Filtek One |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success of the restoration
Clinical success of the restoration will be ranked according to the FDI Clinical Criteria which consider aesthetic, functional, and biological characteristics. The clinical assessment of the investigation criteria will be done by means of a five-score scale. FDI criteria scores 1, 2, and 3 are considered clinically excellent, good, and satisfactory. Score 4 indicates that the restoration is clinically unsatisfactory but repairable, however score 5 indicates that the restoration is clinically poor/failure and should be replaced.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start10 Jul 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class II Dental CariesStudies 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
- Sequential
- Model description
- a randomized controlled split-mouth study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Mohamed S Ellithy, BDS, Principal investigator, Alexandria UniversityRania R Afifi, PhD, Study director, Alexandria UniversityMohamed H Hussein, PhD, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120868
- Sponsor's protocol ID
- 7/2022
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ellithy MS, Abdelrahman MH, Afifi RR. Comparative clinical evaluation between self-adhesive and conventional bulk-fill composites in class II cavities: A 1-year randomized controlled clinical study. J Esthet Restor Dent. 2024 Sep;36(9):1311-1325. doi: 10.1111/jerd.13242. Epub 2024 Apr 24.
PubMed 38655672
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites (a Randomized Controlled Clinical Study)
- ClinicalTrials.gov ID
- NCT06120868
- Acronym / sponsor ID
- 7/2022
- Conditions
- Class II Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 7 Nov 2023 (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.
This study aimed to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring class II cavities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a randomized controlled split-mouth study.
| Arm | Type | Receives |
|---|---|---|
| Surefil one Self-adhesive bulk fill restorative (SABF) | Experimental | Other: Surefil one® |
| Filtek One Bulk Fill (FOBF) | Active comparator | Other: Filtek One |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients in need of restorative treatment on at least two class II Cavities in premolars or molars.
- Presence of proximal caries in digital x-ray with code 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS I).
- Presence of proximal caries in initial or moderate stage according to the International Caries Classification and Management System (ICCMS™).
- Only posterior teeth with class II cavities that have antagonistic contact and at least one proximal contact.
- Absence of parafunctional habits.
Key exclusion criteria (4 listed)
- Serious medical disorders
- Clinical signs of bruxism, traumatic malocclusion
- Pregnant or breast feeding at the time of restoration placement
- Intolerance or allergy toward the applied restorative materials
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 |
|---|---|---|
| Surefil one®For Surefil one® restorations, the capsule will be activated by pressing it against a stable surface, then mixed in a capsule mixer for 10 s. The capsule tip will be inserted into the proximal box, and the material is extruded as the tip is gradually moved in a coronal direction, ensuring that the material adapts to the cavity bottom and walls. | Other | Surefil one Self-adhesive bulk fill restorative (SABF) |
| Filtek OneScotchbond™ Universal (SBU) will be used as an adhesive system in self-etch mode for FiltekTM One restoration. SBU will be applied actively for 20 seconds with a disposable brush tip, air-dried gently for 5 seconds to create a consistent bond thickness, then light-cured for 10 seconds. The FiltekTM One will be packed in increments up to 4 mm thick. A second layer of FiltekTM One will be applied on top of the first 4-mm layer if 4 mm is not adequate to properly restore the tooth. Each increment will be light cured for 20 seconds. | Other | Filtek One Bulk Fill (FOBF) |
Primary outcome
Clinical success of the restoration
Time frame: up to 12 months
Clinical success of the restoration will be ranked according to the FDI Clinical Criteria which consider aesthetic, functional, and biological characteristics. The clinical assessment of the investigation criteria will be done by means of a five-score scale. FDI criteria scores 1, 2, and 3 are considered clinically excellent, good, and satisfactory. Score 4 indicates that the restoration is clinically unsatisfactory but repairable, however score 5 indicates that the restoration is clinically poor/failure and should be replaced.
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 7 Nov 2023.
- Derived from this study: PubMed 38655672Ellithy MS, Abdelrahman MH, Afifi RR. Comparative clinical evaluation between self-adhesive and conventional bulk-fill composites in class II cavities: A 1-year randomized controlled clinical study. J Esthet Restor Dent. 2024 Sep;36(9):1311-1325. doi: 10.1111/jerd.13242. Epub 2024 Apr 24.
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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.
Mohamed S Ellithy, BDS principal investigator
Alexandria University
Rania R Afifi, PhD study director
Alexandria University
Mohamed H Hussein, PhD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surefil one® and Filtek One in people with Class II Dental Caries, run by Nourhan M.Aly 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 6 inclusion and 4 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 7 Nov 2023. 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?
Clinical success of the restoration (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06120868, which also lists 1 linked publication.
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 7 Nov 2023.