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 range18 Years – 70 Years

SexALL

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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

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

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