CompletedNot Applicable

Clinical Performance of Chairside CAD/CAM Restorations

United States58 participantsStarted 2020-08-26

Plain-language summary

This investigation will be a longitudinal clinical trial to study the long-term clinical performance of a resin cement for chairside CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays will be adhesively bonded using a selective enamel etch technique with an adhesive. Full contour zirconia crowns will be cemented using a self-adhesive resin cement.

Who can participate

Age range18 Years – 89 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: * Subject in need of crown and/or onlay restoration * Subject age 18 or above * Subject with healthy / treated periodontal status (max. degree of movement 1) * Subject agrees to participate in the study and signed informed consent and HIPAA form Exclusion Criteria: * Devital or sensitive teeth * Teeth diagnosed with symptoms of incomplete tooth fracture * Teeth with prior endodontic treatment of any kind * Teeth with a history of direct or indirect pulp capping procedures * Subjects with uncontrolled bruxism or parafunctional habits * Subject has known allergies to any product used in this study * Subject will not be available for the study duration * Subjects with significant untreated dental disease to include periodontitis and rampant caries * Pregnant or lactating women

What they're measuring

Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores]

Timeframe: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

Trial details

NCT IDNCT04279574

SponsorSolventum US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-22

Results submitted2025-02-25

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