CompletedNot Applicable

Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth

United States60 participantsStarted 2011-01

Plain-language summary

Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth. Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.

Who can participate

Age range19 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: * 19 years or older * must give written consent * be in good general health * be available for required follow-up visits * have at least 28 teeth Exclusion Criteria: * has rampant, uncontrolled caries * has advanced, untreated periodontal disease * heavy use of smoking tobacco (2 packs or equivalent a day)or chewing tobacco * has systemic or local disorders that contra-indicate the dental procedures needed in this study * has evidence of xerostomia * has evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy * is pregnant at time of screening or tooth restoration * has known sensitivity to acrylates or related materials

What they're measuring

Clinical Performance by Cvar & Ryge Scores

Timeframe: baseline, 6, 12 and 24 months

Clinical Performance by VAS (Pain Scale)

Timeframe: baseline, 6, 12 and 24 months

Trial details

NCT IDNCT01369108

SponsorSolventum US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-09

Results submitted2017-09-19

View on ClinicalTrials.gov More Dental Caries trials