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- Title
A Randomized Proof-of-Principle Bite Force Study of Two Experimental Denture Adhesives and a Commercially Available Adhesive.
- Authors
Jose, Anto; Varghese, Roshan; Roohpour, Nima; Mason, Stephen; Jain, Ritika; Gossweiler, Ana
- Abstract
<bold>Purpose: </bold>To assess the efficacy of two experimental denture adhesive gels (adhesives 1 and 2) compared to a commercially available denture adhesive cream (positive control) and no adhesive (negative control).<bold>Materials and Methods: </bold>This was a single-center, randomized, four-treatment, examiner-blind, crossover study in participants with well-made and at least moderately well-fitting maxillary complete dentures. Incisal bite force until denture dislodgment was measured before application (baseline) and over the following 12 hours for each of the treatments. Between-treatment differences in the area over baseline (AOB) for the bite force at each time point were analyzed using an analysis of covariance model.<bold>Results: </bold>The efficacy and safety analyses were based on results from 48 participants. Compared to the negative control, adhesive 1 showed a statistically significantly higher bite force AOB over 12 hours (AOB0-12h; primary endpoint), as well as for AOB0-6h and AOB0-9h (all P < .05), but not for AOB0-1h or AOB0-3h. Adhesive 2 was not significantly different from the negative control or from adhesive 1 for any measure of AOB. The positive control was associated with a significantly higher bite force AOB than either of the experimental adhesives for all time points (P < .05). Although the positive control was well tolerated, both experimental adhesives were associated with a larger number of oral adverse events.<bold>Conclusion: </bold>Only adhesive 1 was significantly better than the negative control, and its performance did not match that of the positive control. Adhesives 1 and 2 showed the largest number of oral adverse events.
- Subjects
BITES &; stings; HUMAN bites; DENTURE adhesives; REMOVABLE partial dentures; COMPLETE dentures; PHARMACEUTICAL gels; INCISORS; THERAPEUTIC complications; PHYSIOLOGY; ADHESIVES; COMPARATIVE studies; CROSSOVER trials; DENTURES; MASTICATORY muscles; RESEARCH methodology; MEDICAL cooperation; DENTAL occlusion; RESEARCH; STATISTICAL sampling; EVALUATION research; BLIND experiment
- Publication
International Journal of Prosthodontics, 2018, Vol 31, Issue 4, p351
- ISSN
0893-2174
- Publication type
journal article
- DOI
10.11607/ijp.5628