TerminatedNot Applicable

Evaluation of Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin in Restorations of NCCLs

Stopped: Due to slow recruitment.

Italy16 participantsStarted 2022-09-21

Plain-language 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). The study consists of a 3-year long follow-up period.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of Restorative Quality

Timeframe: At 36 months follow-up.

Assessment of Restorative Quality

Timeframe: At 36 months follow-up

Trial details

NCT IDNCT05751382

SponsorDentsply Sirona Implants and Consumables

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-22

Results submitted2024-02-13

View on ClinicalTrials.gov More Tooth Restoration trials