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

ABSTRACT: 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 (Clinicaltrials.gov: NCT02937870).

SUBMITTER: Atassi M

PROVIDER: S-EPMC7133722 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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

Atassi Mounir M Ling Martin R MR Oneglia Kathy K Dilauro Thomas S TS

Clinical and experimental dental research 20200206 2

<h4>Objectives</h4>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 (AOB<sub>0-12</sub> ) in participants with an at least moderately well-fitting complete maxillary denture. Previous in vitro studies sugg ...[more]

PMID: 32026625

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Project description:ObjectivesAn 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 methodsParticipants 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.ResultsIn 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.ConclusionsThese 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.

Project description:PURPOSE:To study the effects of denture adhesive upon denture micromovements in three dimensions during the chewing of hard, sticky, and tough food items observed using a novel method involving an electromagnetic articulograph (EMA) speech research system. MATERIALS AND METHODS:Ten volunteers (mean age 60.9 ± 10.4 years) with fair- or poor-fitting complete maxillary dentures were enrolled. Chewing experiments were conducted using two treatments (adhesive or no-adhesive control) and three foods: carrots (hard), raisins (sticky), and processed meat stick (tough). Denture micromovement was measured through a novel application of a Northern Digital Wave EMA System. Three-dimensional denture position was captured during mastication using three sensors embedded into a replica denture for each subject. Following individual characterization of a "home" reference position, the Euclidean Distances from Home (DfH) were calculated for each recorded sample of the chewing experiments. The DfH at each sample represented the denture movement for that 1/100th of a second of the activity. The DfH data were then summarized as the mean DfH, the maximum DfH, and total distance traveled by the denture. Several thresholds were also analyzed, including the percent of time that the DfH ≥1.5 mm, ≥2.0 mm, and ≥2.5 mm. RESULTS:With adhesive treatment, the mean DfH of dentures during chewing was reduced by 26.8% for carrot, 30.3% for raisin, and 31.0% for meat stick, when compared with no-adhesive treatment (p < 0.001 for all comparisons). Similar results were also seen for the maximum DfH and total distance travelled endpoints across foods. For the threshold endpoints, adhesive treatment was associated with a statistically significant reduction in denture micromovements at all three thresholds across foods. At the threshold of DfH ≥ 1.5 mm, adhesive treatment was associated with a reduction in micromovement by 61.6%, 56.2%, and 70.0% with carrot, raisin, and meat stick, respectively (p ≤ 0.004 for all comparisons). CONCLUSIONS:Observations of denture movement using the Wave EMA System were able to differentiate systematically between adhesive treatment and no-adhesive treatment for denture micromovements during different chewing challenges. Use of adhesive was associated with statistically significant reductions in denture micromovements for hard, sticky, and tough foods as measured with both distance and threshold endpoints.

Project description:In this work we demonstrate a novel method of methylation detection that utilises immunoaffinity to detect the presence of methylated DNA hybridised to a cDNA microarray. We use a monoclonal antibody specific to 5 methylcytosine to detect the presence of 5 methylcytosine in genomic DNA from human fibroblasts bearing the karyotype 45 XO. We report that over 2900 genes show the presence of methylation in this condition. We also report that 165 genes are consistently methylated in all replicates of these experiments. The methylated genes show a uniform distribution over all the chromosomes. The gene ontology of these also indicates no functional correlation between the genes that are methylated. We detect the presence of methylation in IGF2, an imprinted gene and thus known to harbour DNA methylation. The method is extremely specific and offers a quick and efficient way to analyse the methylation landscape on a high throughput scale. This method uses existing technology to assess methylation and thus can integrate very efficiently into any platform used. A method that detects DNA methylation that is not restricted to specific sequences would provide a useful platform to analyse methylation distribution among the genes in any given phenotypic condition.Availability of additional approaches to examine DNA methylation would lead to increase in our understanding of the methylome and would help define the intrinsic and extrinsic factors which govern it. Microarray based high throughput methods have been extensively used for gene expression analysis. The method described uses a microarray to analyse DNA methylation levels in a gene/cDNA/oligo specific manner. Here, genomic DNA is fragmented and used for hybridization to microarray slides. The presence of DNA cytosine methylation in the hybridized DNA is detected by employing Cy3 labelled anti 5mC( 5-methyl cytidine) antibody (monoclonal). The resolution provided by this method is dependent upon the microarray platform used. This method can be adapted to any platform thus enabling seamless integration with existing technology of gene expression analysis

Project description:BackgroundDenture adhesives can be useful in improving patients' satisfaction with complete dentures. However, comparison clinical trials are lacking. The purpose of this randomized clinical trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with 3 types of denture adhesives.MethodsSixty-four completely edentulous patients seeking complete dentures for their first time were randomly divided into 3 groups. Each group received a set of complete dentures, which were adjusted at review appointments until participants reported no complaints. After 1 month of using the dentures, participants rated their overall satisfaction and their satisfaction regarding comfort, retention, stability, and efficiency of mastication and speech on a 100-mm visual analog scale (VAS). Participants also filled out the oral health impact profile for edentulous patients (OHIP-EDENT) questionnaire. Each group was then given 1 type of denture adhesive to use. Group C received Corega Ultra denture fixative cream (GlaxoSmithKline), Group O received Olivafix (Bonyf), and Group S received Sea. Bond adhesive strips (Sea.Bond). Mann-Whitney U test was used to analyze the differences in VAS scores before and after using the adhesive within each group and Wilcoxon-signed rank test was used to compare OHIP scores and total OHIP values before and after using the adhesive within each group (p = 0.05). Furthermore, Kruskal Wallis test was used to compare the differences before and after using the adhesives in VAS and OHIP values between the 3 groups.ResultsSignificantly higher VAS values were detected in all groups and significantly lower values for many OHIP items in addition to total OHIP values were detected in all groups after using the adhesives (P < 0.05), except for the ease of cleaning for Group O and Group S (P > 0.05). No significant differences were found in VAS and OHIP values between the 3 groups (P > 0.05), except for the ease of cleaning which was significantly different between Group C and Group S (p = 0.005).ConclusionsUsing denture adhesives for completely edentulous patients resulted in higher patient satisfaction as indicated by higher VAS scores as well as improved quality of life as indicated by lower OHIP-EDENT scores after using the adhesives. These improvements were not dependent on the type of adhesive, except for ease of cleaning as adhesive strips were easier to clean than paste type adhesives.Trial registrationThis trial was registered at ClinicalTrials.gov (ID: NCT05496283) on 11/08/2022.

Dataset Information

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

Publications

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

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