Tooth RestorationNCT05751382
Evaluation of Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin in Restorations of NCCLs
A study testing Surefil one and Venus Pearl in people with Tooth Restoration, run by Dentsply Sirona Implants and Consumables at 1 site in Italy.
Trial summary
This is a split-mouth randomized clinical investigation conducted to evaluate clinical performances of a self-adhesive hybrid resin composite (investigational medical device Surefil) compared to a traditional composite resin, when used for direct restorations of non-carious lesions (NCCLs). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tooth Restoration
- What is being tested?
- Surefil one and Venus Pearl
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 21 Sep 2022to 22 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aging from 18 to 70
- 40-60% women, 40-60% men
- Patients who present at least 2 cervical lesions on canines and / or upper premolars on vital teeth
- Patients who are not allergic or sensitive to the ingredients contained in the products
- The test patient consents to the restorative treatment in line with the study´s criteria (informed consent)
- Sufficiently understanding of the language
Who cannot join
- Extremely low level of oral hygiene
- Teeth with previous restorations
- Not possible adequate isolation of the operating area
- Patients with serious systemic diseases
- Devitalized teeth or with pulpitis in progress
- Periodontal problems on the elements to be restored
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3-year Evaluation of the Clinical Performances of a Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin Used for Direct Restorations of Non-carious Cervical Lesions (NCCLs): A Split-mouth Randomized Clinical Trial
This is a split-mouth randomized clinical investigation conducted to evaluate clinical performances of a self-adhesive hybrid resin composite (investigational medical device Surefil) compared to a traditional composite resin, when used for direct restorations of non-carious lesions (NCCLs). The study consists of a 3-year long follow-up period.
Read the detailed description
The aim of this study is to demonstrate non-inferiority in terms of clinical performance and patient discomfort after direct restorative treatment of class V NCCL with Surefil one restorative material (Dentsply Sirona) in combination with a traditional paste composite "Venus Pearl" employed in combination with iBond universal adhesive (Kulzer Dental) during an observational period of 3 years.
- Conditions
- Tooth Restoration
- Being tested
- Surefil one, Venus Pearl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surefil oneDevice
Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL.
Venus PearlDevice
Restorative material. Traditional paste composite employed in combination with iBond universal adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Restoration with Surefil one hybrid composite | Experimental | In a split-mouth design, subjects were randomly assigned to restoration with Surefil one hybrid composite in either the left or the right upper quadrant.
Restoration performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 seconds with a LED lamp (Smartlamp Pro). Receives: Device: Surefil one |
| Restoration with Venus Pearl composite | Active comparator | In a split-mouth design, subjects were randomly assigned to restoration with Venus Pearl composite in either the left or the right upper quadrant.
After the application of the adhesive system (iBond universal), the Venus Pearl composite will be layered on the cavity and cured for 20 seconds with a LED lamp Smartlamp Pro). Receives: Device: Venus Pearl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Restorative Quality
The restorations will be evaluated using the World Dental Federation (FDI) criteria.
Measured: At 36 months follow-up.
Assessment of Restorative Quality
The restorations will be evaluated using the United States Public Health Service (USPHS) criteria.
Measured: At 36 months follow-up
Secondary outcomes (4)
Assessment of Restorative Quality
The restorations will be evaluated using the FDI criteria.
Measured: At 6, 12 and 24 months follow-up
Assessment of Restorative Quality
The restorations will be evaluated using the USPHS criteria.
Measured: At 6, 12 and 24 months follow-up
Assessment of Aesthetics
The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI.
Measured: At 6, 12, 24 and 36 months follow-up
Level of Pain
Sensitivity index: thermal yes/no, if yes then Visual Analogue Scale (VAS) index for level of pain. Air yes/no, if yes then VAS index for level of pain.
Measured: At 6, 12, 24 and 36 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start21 Sep 2022
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Why it stopped: Due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tooth 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
- Model description
- Split-mouth design, i.e. each subject have both treatment arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Breschi, Prof, Principal investigator, Clinica Odontoiatrica (DIBINEM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751382
- Sponsor's protocol ID
- 14.1535
- Status last verified
- Nov 2024
- First submitted
- 7 Feb 2023
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-year Evaluation of the Clinical Performances of a Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin Used for Direct Restorations of Non-carious Cervical Lesions (NCCLs): A Split-mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05751382
- Acronym / sponsor ID
- 14.1535
- Conditions
- Tooth Restoration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow recruitment.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a split-mouth randomized clinical investigation conducted to evaluate clinical performances of a self-adhesive hybrid resin composite (investigational medical device Surefil) compared to a traditional composite resin, when used for direct restorations of non-carious lesions (NCCLs). The study consists of a 3-year long follow-up period.
Detailed description
The aim of this study is to demonstrate non-inferiority in terms of clinical performance and patient discomfort after direct restorative treatment of class V NCCL with Surefil one restorative material (Dentsply Sirona) in combination with a traditional paste composite "Venus Pearl" employed in combination with iBond universal adhesive (Kulzer Dental) during an observational period of 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design, i.e. each subject have both treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Restoration with Surefil one hybrid composite | Experimental | Device: Surefil oneIn a split-mouth design, subjects were randomly assigned to restoration with Surefil one hybrid composite in either the left or the right upper quadrant. Restoration performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 seconds with a LED lamp (Smartlamp Pro). |
| Restoration with Venus Pearl composite | Active comparator | Device: Venus PearlIn a split-mouth design, subjects were randomly assigned to restoration with Venus Pearl composite in either the left or the right upper quadrant. After the application of the adhesive system (iBond universal), the Venus Pearl composite will be layered on the cavity and cured for 20 seconds with a LED lamp Smartlamp Pro). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aging from 18 to 70
- 40-60% women, 40-60% men
- Patients who present at least 2 cervical lesions on canines and / or upper premolars on vital teeth
- Patients who are not allergic or sensitive to the ingredients contained in the products
- The test patient consents to the restorative treatment in line with the study´s criteria (informed consent)
Key exclusion criteria (6 listed)
- Extremely low level of oral hygiene
- Teeth with previous restorations
- Not possible adequate isolation of the operating area
- Patients with serious systemic diseases
- Devitalized teeth or with pulpitis in progress
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 oneRestorative material (Dentsply Sirona). Used for direct restoration of class V NCCL. | Device | Restoration with Surefil one hybrid composite |
| Venus PearlRestorative material. Traditional paste composite employed in combination with iBond universal adhesive. | Device | Restoration with Venus Pearl composite |
Primary outcome
Assessment of Restorative Quality
Time frame: At 36 months follow-up.
The restorations will be evaluated using the World Dental Federation (FDI) criteria.
Assessment of Restorative Quality
Time frame: At 36 months follow-up
The restorations will be evaluated using the United States Public Health Service (USPHS) criteria.
4 secondary outcomes
Assessment of Restorative Quality
Time frame: At 6, 12 and 24 months follow-up
Assessment of Restorative Quality
Time frame: At 6, 12 and 24 months follow-up
Assessment of Aesthetics
Time frame: At 6, 12, 24 and 36 months follow-up
Level of Pain
Time frame: At 6, 12, 24 and 36 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lorenzo Breschi, Prof principal investigator
Clinica Odontoiatrica (DIBINEM)
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 Venus Pearl in people with Tooth Restoration, run by Dentsply Sirona Implants and Consumables at 1 site in Italy.
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 6 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: stopped early, as of the sponsor's last update on 13 Jan 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 Italy. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Restorative Quality (time frame: At 36 months follow-up.). The study lists 2 primary outcomes in all. 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 13 Jan 2025.