CompletedPhase 3

A Clinical Study to Evaluate the Maximum Maxillary Bite Force (BF) When Using Two Novel Denture Adhesives Compared to Using No-Adhesive

United States45 participantsStarted 2022-02-08

Plain-language summary

The purpose of this study is to investigate the hold properties of two experimental denture adhesives using established maximum incisal BF methodology.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. At least moderately well-fitting (Kapur Index, Olshan Modification: retention score Greater than or equal to (\>=)2, stability score \>=2) at the Screening (V1) visit,
✓. Is well made (according to the well-made assessment).
✓. The qualifying BF measurements (without adhesive) at V1 (Screening) must be less than or equal to (=\<) 9lbs.
✓. At least 2 of the 4 qualifying BF measurements (without adhesive) at V1 (Screening) must be reproducible (within +-2lbs).
✓. The Baseline BF measurement (without adhesive) at V2-5 must be \<=9lbs.
✓. The Baseline BF measurement (without adhesive) at V2-5 and at least 1 of the 3 practice BF measurements must be within +-2lbs of each other.
✓. sufficiently stable, in the opinion of the investigator, to enable the bite force determination to be performed.
✓. well made (according to the well-made assessment).

What they're measuring

Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force

Timeframe: Baseline and up to 12 hours

Trial details

NCT IDNCT05173974

SponsorHALEON

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-12

Results submitted2023-06-09

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