A Randomized Proof-of-Principle Bite Force Study of Two Experimental Denture Adhesives and a Commercially Available Adhesive

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Unlike other oral care products, there are limited technologies in the denture adhesive category with the majority based on polymethyl vinyl ether/maleic anhydride (PVM/MA) polymer. Carbomer‐based denture adhesives are less well studied, and there are few clinical studies directly comparing performance of denture adhesives based on different technologies. This single‐centre, randomised, three‐treatment, three‐period, examiner‐blind, crossover study compared a carbomer‐based denture adhesive (Test adhesive) with a PVM/MA‐based adhesive (Reference adhesive) and no adhesive using incisal bite force measurements (area over baseline over 12 hr; AOB0–12) in participants with a well‐made and at least moderately well‐fitting complete maxillary denture. Eligible participants were randomised to a treatment sequence and bit on a force transducer with increasing force until their maxillary denture dislodged. This procedure was performed prior to treatment application (baseline) and at 0.5, 1, 3, 6, 9, and 12 hr following application. Forty‐four participants were included in the modified intent‐to‐treat population. AOB0–12 favoured both Test adhesive to No adhesive (difference: 2.12 lbs; 95% CI [1.25, 3.00]; p < 0.0001) and Reference adhesive to No adhesive (difference: 2.76 lbs; 95% CI [1.89, 3.63]; p < 0.0001). There was a numerical difference in AOB0–12 for Test versus Reference adhesive (−0.63 lbs; [−1.51, 0.25]); however, this was not statistically significant (p = 0.1555). Treatments were generally well tolerated. Both PVM/MA and carbomer‐based denture adhesives demonstrated statistically significantly superior denture retention compared with no adhesive over 12 hr, with no statistically significant difference between adhesives.

Section: Methodsmentioning

confidence: 99%

“…No further significance testing would be performed if the initial validation step was not achieved. The reason for this validation step was to ensure that the study methodology had been performed as expected, the superior performance of the Reference adhesive over No adhesive having been demonstrated previously (Jose et al, ).…”

Section: Methodsmentioning

confidence: 99%

A randomised bite force study assessing two currently marketed denture adhesive products compared with no‐adhesive control

Varghese¹,

Burnett²,

Souverain³

et al. 2019

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“…Furthermore, no statistically significant difference was observed between the marketed reference adhesive and no adhesive for AOB 0–12 . This was unexpected given the results of previous studies of similar design that found that the reference adhesive used here demonstrated statistically significantly greater incisal bite force until dislodgement compared with no adhesive (Jose et al, ). In the current study, the mean AOB 0–12 values were 1.39 with no adhesive and 2.07 with the reference adhesive.…”

Section: Discussionmentioning

confidence: 51%

“…In the current study, the mean AOB 0–12 values were 1.39 with no adhesive and 2.07 with the reference adhesive. In previous studies, mean AOB 0–12 with no adhesive was slightly higher at around 2.15, whereas mean AOB 0–12 with the reference adhesive was much higher, at around 4.79 (Burnett et al, ; Jose et al, ).…”

Section: Discussionmentioning

confidence: 84%

“…Here, the incisal bite force until maxillary denture dislodgement clinical model is used. This has been used previously to determine denture adhesive efficacy between 1 and 12 hr after application and to demonstrate differences between adhesive formulations (Chew, Boone, Swartz, & Philips, ; Chew, Phillips, Boone, & Swartz, ; Grasso, ; Jose et al, ; Munoz et al, ).…”

Section: Introductionmentioning

confidence: 99%

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A proof‐of‐principle bite force study using two experimental test denture adhesives and a currently marketed denture adhesive

Atassi¹,

Ling²,

Oneglia

et al. 2020

Objectives This proof‐of‐principle, single‐center, randomized, examiner‐blind, crossover study compared two experimental polyvinyl acetate (PVA)‐based denture adhesives (Test Adhesives 1 and 2) with a marketed reference polymethyl vinyl ether/maleic anhydride (PMV/MA)‐based adhesive and no adhesive using incisal bite force area over baseline over 12 hr (AOB0–12) in participants with an at least moderately well‐fitting complete maxillary denture. Previous in vitro studies suggested the experimental denture adhesives provided superior performance. Materials and Methods Participants were randomized to a treatment sequence such that each received each treatment once. Prior to treatment application (baseline) and at 0.5, 1, 3, 6, 9, and 12 hr following the application, participants bit on a force transducer until their maxillary denture dislodged. Between‐treatment differences in AOB0–12 were analyzed using analysis of covariance. For study validity, the reference adhesive was compared with no adhesive. Participants were asked to rate sensory experiences and ease of denture removal. Results Twenty‐three participants were included in the modified intent‐to‐treat population. Although Test Adhesives 1 and 2 had a higher mean AOB0–12 than no adhesive, differences were not statistically significant. No statistically significant difference was also found between the reference adhesive and no adhesive; hence, study validity was not attained. Participants did not report any clear differences between the test or reference adhesives in terms of taste or feel; however, dentures were easier to remove with the test adhesives versus reference. No treatment‐related adverse events were reported. Conclusion Neither the experimental PVA‐based denture adhesives nor the PMV/MA‐based reference product demonstrated a statistically significant difference in incisal bite force AOB0‐12 compared with no adhesive. The reasons for these unexpected results is unclear; they suggest that findings of in vitro tests for denture adhesive performance are not always translated to in vivo performance (http://Clinicaltrials.gov: NCT02937870).

A randomized clinical study to assess the performance of a marketed denture adhesive in a model of food infiltration in healthy, edentulous adults

Patel¹,

Varghese²,

Burnett³

et al. 2022

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Objectives An optimized food infiltration methodology was utilized to assess the objective and subjective efficacy of a marketed denture adhesive regarding denture dislodgment and infiltration and perception of food particles under maxillary and mandibular dentures. A pilot study helped optimize methodologies before the efficacy study. Materials and Methods Participants were healthy adults ( n =48 for both studies) with fair‐ to well‐fitting and well‐made full maxillary and mandibular dentures. In the pilot, groups were a denture adhesive applied in a conventional dabbed‐on pattern, a denture adhesive applied in continuous strips, or no adhesive. In the efficacy study, groups were the Test denture adhesive (continuous strips pattern application) or no adhesive, employed in a crossover design. Food infiltration was investigated through measurement of peanut particle mass retrieved from under each denture (30–32 g chewed). No formal statistical testing was performed in the pilot. Statistical analysis in the efficacy study was performed using analysis of variance. Primary efficacy evaluation was combined peanut particle mass from both dentures. Secondary efficacy evaluations included peanut particle mass under separate dentures, participant‐reported denture dislodgements, and awareness/rates of how bothersome peanut particles under dentures were. Results In the pilot, the median peanut particle mass was lower with either pattern application compared with no adhesive. In the efficacy study, peanut particle mass under combined dentures was lower with than without adhesive (geometric mean [product of values]: 5.56 vs. 29.13 mg) with a between‐group geometric mean ratio (adhesive over no adhesive) of 0.19 (95% confidence interval: 0.12, 0.30) favoring the Test adhesive ( p < .0001). Similar Test adhesive beneficial outcomes in both studies included significantly fewer denture dislodgements and awareness and how bothersome peanut particles under dentures were. Treatments were generally well‐tolerated. Conclusions These findings, including reduced peanut particle infiltration, fewer denture dislodgments, and lower ratings of bothersomeness, corroborate those studies investigating the benefits of denture adhesive in preventing food infiltration.