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Published on: December 26, 2016
A randomized crossover trial assessing denture adhesive for prevention of food infiltration among partial denture
Julie Grender1, Malgorzata Klukowska2, Kimberly Milleman3
1The Procter & Gamble Company, Mason, Ohio, USA, grender.jm@pg.com.
Purpose:
This two-treatment, four-period, double-blind, randomized controlled crossover trial assessed the ability of two denture adhesives, both applied with a thin nozzle in a continuous application pattern, to prevent food infiltration beneath partial dentures.
Methods:
Participants with mandibular partial dentures and a history of food particle infiltration were enrolled. All participants used both an optimized calcium/zinc partial salt of polyvinyl methyl ether/maleic acid (PVM/MA) denture adhesive and a calcium/sodium partial salt of PVM/MA test denture adhesive, twice each, throughout four study periods, according to a randomly assigned sequence. At each visit, participants underwent two assessments: once with no denture adhesive (baseline) and once with denture adhesive, 1 hour after adhesive application. For each assessment, participants ate one-half of the top of a poppy seed muffin, and a dental professional counted the seeds retained on the denture and mucosa, which was the primary variable. The change-from-baseline comparison was made for each treatment separately using a paired t-test or Wilcoxon Signed Rank test depending on the normality of the data. A between-treatment comparison for the change from baseline was performed using a crossover ANCOVA with treatment and period as fixed effects and participant as a random effect. The baseline poppy seed count was used as a covariate.
Results:
30 participants were enrolled; 29 completed the trial. Both denture adhesives achieved statistically significantly fewer retained seeds versus baseline (P< 0.001). The calcium/zinc adhesive reduced the seed count from baseline by 85.9% (6.18 vs 0.86), and the calcium/ sodium adhesive reduced seed count by 76.6% (6.04 vs 1.43). Comparing the two denture adhesives, the reduction in seed count from baseline was statistically significantly greater for the calcium/zinc adhesive versus the calcium/sodium formulation (P= 0.008).
Clinical Significance:
These results support the recommendation of denture adhesive use for the prevention of food infiltration beneath partial dentures, with optimized calcium/zinc denture adhesive showing the greatest prevention benefit.
