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

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.

Eating Advice for People Who Wear Dentures: A Scoping Review.

OBJECTIVE: A scoping review of available advice to address eating problems experienced by people who wear dentures was conducted in accordance with the PRISMA statement. The objective was to identify and map type, volume, and content of the available eating advice. METHODS: Medline, CINAHL, and grey literature databases and Google were searched. Relevant content pertaining to study type, peer-review vs. grey literature, country of origin, advice content, and methods to evaluate effectiveness was mapped. RESULTS: Of the 4591 records identified from peer-reviewed literature, 56 full papers underwent duplicate screening, resulting in 26 papers (from Germany (n = 1), Europe (n = 1), India (n = 2), Japan (n = 7), UK (n = 6), USA (n = 6), or other (n = 3)) being included in the review. These yielded 18 different items of relevant eating advice. Of the 258 screened websites, 63 were included, yielding 30 different items of eating advice. The most-cited advice was to eat soft food and avoid hard and sticky food, cut food into bite-sized pieces, and chew on both sides of the mouth and chew slowly and thoroughly. The identified advice was not supported by reference to peer-reviewed evidence. Advice included some conflicting messages and some advice was non-compliant with authoritative nutritional advice (e.g., avoid red meat, take a vitamin supplement). CONCLUSION: There is support for providing eating advice at the time of denture provision. A broad range of advice based on clinical experience to support people who wear dentures to overcome the functional limitations exists. However, the efficacy of this advice in improving diet and eating experience has not been tested.

Numerical study of the stress state on the oral mucosa and abutment tooth upon insertion of partial dentures in the mandible.

The introduction of a removable partial denture onto the dental arch significantly influences the mechanical stress characteristics of both the jawbone and oral mucosa. The aim of this study was to analyze the stress state caused by biting forces upon insertion of partial dentures into the assembly, and to understand the influence of the resulting contact pressure on its retention behavior. For this purpose, a numerical model of a removable partial denture is proposed based on 3D models developed using computer tomography data of the jawbone and the removable partial denture. The denture system rests on the oral mucosa surface and three abutment teeth. The application of bite forces on the denture generated a stick condition on the loaded regions of the denture-oral mucosa interface, which indicates positive retention of the denture onto the oral mucosa surface. Slip and negative retention were observed in the regions of the contact space that were not directly loaded. The contact pressures observed in the regions of the oral mucosa in contact with the denture were below the clinical pressure pain threshold value for soft tissue, which potentially lowers the risk of pain being experienced by denture users. Further, the variation of the retention behavior and contact pressures across different regions of the denture assembly was observed. Thus, there is a need for adhesives or restraining mechanisms for the denture system in order to avoid bending and deformation of sections of the denture as a consequence of the applied bite force.

Nutritional Assessment of Denture Wearers Using Matched Electronic Dental-Health Record Data.

PURPOSE: To assess the nutritional profile of denture wearers through a retrospective cohort study using nutritional biomarkers from matched electronic dental and health record (EDR-EHR) data. MATERIALS AND METHODS: The case group (denture wearers) included matched EDR-EHR data of patients who received removable partial, complete, and implant-supported prosthodontic treatments between January 1, 2010 and December 31, 2018, study time. The control (nondenture wearers) group did not have recorded denture treatments and included patient records within 1 year of the denture index date (first date of case patients' receiving complete or partial denture) of the matching cases. The qualified patients' EDR were matched with their EHR based on the availability of laboratory reports within 2 years of receiving the dentures (index date). Nutritional biomarkers were selected from laboratory reports for complete blood count, comprehensive and basic metabolic profile, lipid, and thyroid panels. Summary statistics were performed, and general linear mixed effect models were used to evaluate the rate of change over time (slope) of nutritional biomarkers before and after the index date. Likelihood ratio tests were performed to determine the differences between dentures and controls. RESULTS: The final cohort included 10,481 matched EDR-EHR data with 3,519 denture wearers and 6,962 controls that contained laboratory results within the study time. The denture wearers' mean age was 57 ±10 years and the control group was 56 ±10 years with 55% females in both groups. Pre-post analysis among denture wearers revealed decreased serum albumin (p = 0.002), calcium (p = 0.039), creatinine (p < 0.001) during the post-index time. Hemoglobin (Hb) was higher pre-index, and was decreasing during the time period but did not change post-index (p < 0.001). Among denture wearers, completely edentulous patients had a significant decrease in serum albumin, creatinine, blood urea nitrogen (BUN), but increased estimated glomerular filtration rate (eGFR). In partially edentulous patients, total cholesterol decreased (p = 0.018) and TSH (p = 0.004), BUN (p < 0.001) increased post-index. Patients edentulous in either upper or lower arch had decreased BUN and eGFR during post-index. Compared to controls, denture wearers showed decreased serum albumin and protein (p = 0.008), serum calcium (p = 0.001), and controls showed increased Hb (p = 0.035) during post-index. CONCLUSIONS: The study results indicate nutritional biomarker variations among denture wearers suggesting a risk for undernutrition and the potential of using selected nutritional biomarkers to monitor nutritional profile.

Development of a United Kingdom-centric cost-effectiveness model for denture cleaning strategies.

STATEMENT OF PROBLEM: Denture stomatitis is a prevalent condition in denture wearers. Economic evaluations of health care can help stakeholders, including patients, make better decisions about treatments for a given condition. Economic models to assess the costs and benefits of different options for managing denture stomatitis are lacking. PURPOSE: The purpose of this study was to explore the feasibility of developing a cost-effectiveness model to assess denture cleaning strategies aimed at preventing denture stomatitis from a denture-wearer perspective in the United Kingdom. MATERIAL AND METHODS: A model was developed to identify and estimate the costs and effects associated with 3 denture cleaning strategies. These were low care (LC)-cleaning by brushing and soaking overnight in water; medium care (MC)-brushing with toothpaste and soaking overnight in water; and optimum care (OC)-brushing and soaking overnight in water and antimicrobial denture cleanser. Costs, outcome measures (denture stomatitis-free days), and probabilities (incidence of stomatitis, unscheduled dentist visits, prescription charges, self-medication) associated with each strategy were defined. A sensitivity analysis was used to identify key drivers and test the robustness of the model. RESULTS: The model showed that the total costs for 2015 ranged from £1.07 (LC) to £18.42 (OC). Costs associated with LC were derived from unscheduled dentist visits and use of medication and/or prescription charges. Incremental costs per denture stomatitis-free day were £0.64 (MC) and £1.81 (OC) compared with LC. A sensitivity analysis showed that varying either or both key parameters (baseline incidence of denture stomatitis and relative effectiveness of MC and OC strategies) had a substantial effect. Incremental cost-effectiveness ratios ranged from £4.11 to £7.39 (worst-case scenario) and from £0.21 to £0.61 (best-case scenario). CONCLUSIONS: A model was developed to assess the relative cost-effectiveness of different denture cleaning strategies to help improve denture hygiene. An important finding of the study was the lack of evidence on the relative effectiveness of different cleaning strategies, meaning that several assumptions had to be incorporated into the model. The model output would therefore likely be considerably improved and more robust if these evidence gaps were filled.

Understanding the impact of removable partial dentures on patients' lives and their attitudes to oral care.

Introduction Due to a rising prevalence of removable partial denture (RPD) use, there is an unmet need to explore the psychological impact on patient wellbeing.Aim To assess the psychological effects of consumers losing teeth and receiving partial dentures to better manage their needs.Design Four market research surveys, undertaken on behalf of GlaxoSmithKline Consumer Healthcare, are described.Setting Surveys were conducted across the US, Japan, Malaysia, Colombia, Brazil, Poland and Italy.Materials and methods Quantitative/qualitative methods were used to gain knowledge regarding patients' experiences living with partial dentures.Results In a global market research survey involving 3,952 RPD wearers (RPDWs), 54% said that losing teeth was difficult to accept, 40% were concerned about their appearance, 32% were embarrassed about wearing dentures and 62% wished that more oral care education was available when they were younger. In another survey of >1,000 RPDWs, self-esteem was negatively impacted in 51% of respondents and 57% reported anxiety around dental visits.Conclusions Global market research confirmed that RPDWs can have emotional and practical needs that are not well understood/documented by dental healthcare professionals (HCPs). Consumer research can enhance understanding of patients' needs by dental HCPs and provide suggestions about how they may address them.

Finite Element Evaluation of the Effect of Adhesive Creams on the Stress State of Dentures and Oral Mucosa.

The base fit between a removable partial denture (RPD) and the underlying soft tissue plays a significant role in its performance. The application of a denture adhesive is hypothesized to result in better retention of RPDs and, as a result, contribute to lower stress on the oral mucosa. The objectives of this study were to observe and compare the distribution of simulated bite forces applied to the RPD through the abutments and soft tissue for models with and without the use of a denture adhesive. Furthermore, we evaluated the possible benefit of using a denture adhesive in lowering stresses on the oral mucosa. The RPD, mandible, oral mucosa, abutment teeth supporting the RPD, and the corresponding abutment periodontal ligaments (PDLs) were modelled as 3D volumes based on computer tomography (CT) datasets. A viscoelastic adhesive layer between the RPD and oral mucosa was incorporated into this base model using Prony series approximation. The layer was developed as a volume extract using the denture surface. Finite element (FE) simulations were performed for the bite force on one of the RPD segments, with the resulting force and moments experienced by the dental structures and oral mucosa compared between the model with the adhesive layer and the base model without. As a result, the contact pressure on the oral mucosa for the model with the denture adhesive decreased to 0.15 MPa as compared to 0.25 MPa for the model without the adhesive. The potential role of denture adhesives in leading to a better fit between the RPD and oral mucosa as well as lowering contact pressures could be used to improve comfort in patients wearing RPDs.

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

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.

Impact of frequency of denture cleaning on microbial and clinical parameters - a bench to chairside approach.

Objective: Robust scientific and clinical evidence of how to appropriately manage denture plaque is lacking. This two-part study (i) developed an in vitro model of denture plaque removal, and (ii) assessed effectiveness of these approaches in a randomised clinical trial. Method: (i) a complex denture plaque model was developed using the dominant microbial genera from a recent microbiome analyses. Biofilms formed on polymethylmethacrylate were brushed daily with a wet toothbrush, then either treated daily for 5 days or only on Days 1 and 5 with Polident® denture cleanser tablets (3 min soaking). Quantitative and qualitative microbiological assessments were performed. (ii), an examiner-blind, randomised, crossover study of complete maxillary denture wearers was performed (n = 19). Either once-daily for 7 days or on Day 7 only, participants soaked dentures for 15 min using Corega® denture cleansing tables, then brushed. Denture plaque microbiological assessment used sterilized filter paper discs. Results: The in vitro model showed daily cleaning with denture cleanser plus brushing significantly reduced microbial numbers compared to intermittent denture cleaning with daily brushing (p < 0.001). The clinical component of the study showed a statistically significant reduction in denture plaque microbial numbers in favour of daily versus weekly treatment (aerobic bacteria p = 0.0144). Both in vitro and in vivo studies showed that denture plaque biofilm composition were affected by different treatment arms. Conclusions: This study demonstrated that daily denture cleansing regimens are superior to intermittent denture cleansing, and that cleansing regimens can induce denture plaque compositional changes. Clinicaltrials.gov registration: NCT02780661.

A randomized controlled study to evaluate an experimental moisturizing mouthwash formulation in participants experiencing dry mouth symptoms.

OBJECTIVE: The aim of this study was to evaluate the efficacy and tolerability of an experimental moisturizing mouthwash versus water only in participants experiencing dry mouth symptoms, including those with Sjögren syndrome (n = 28). STUDY DESIGN: Participants were randomized to the experimental mouthwash group (n = 53) or the water-only group (n = 47). For 8 days, the mouthwash group used 1 to 2 doses/day at home; both groups could sip water, as needed. Supervised treatment occurred on days 1, 3, and 8, and during this treatment, before and after administration, participants completed the Product Performance and Attributes Questionnaire parts 1 through 4. RESULTS: Significant between-treatment differences on all Product Performance and Attributes Questionnaire questions were shown at most time points. On day 8, at 120 minutes, there was a significant difference on Product Performance and Attributes Questionnaire 3-Question 1 ("Relieves the discomfort of dry mouth"; the predefined primary efficacy variable) in favor of mouthwash versus water (0.63 [95% confidence interval 0.17-1.10]; P = .0084). Subgroup analysis found a significant difference that favored mouthwash in participants without Sjögren syndrome (0.67 [0.11,1.23]; P = .0203) but not with Sjögren syndrome (0.52 [-0.35,1.38; P = .2272). Eight, non-serious, oral treatment-related adverse events were reported by the mouthwash group. CONCLUSIONS: The findings of a subjective questionnaire showed that an experimental moisturizing mouthwash provided greater relief than water only from dry mouth symptoms over 8 days.

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

PURPOSE: 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). MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Randomized Clinical Study Comparing Three Experimental Denture Adhesives and Fixodent® versus No Adhesive.

OBJECTIVES: Denture adhesives can improve function, retention, stability, and bite force in well-fitting dentures. This single-center, randomized, five-arm, examiner-blind, crossover clinical study aimed to compare three experimental adhesives ("Adhesive 1," "Adhesive 2," "Adhesive 3") with slightly different formulations and a commercially marketed "Positive control" with a "No Adhesive" arm using incisal bite force measurements over 12 hours in subjects with a moderately well- to well-fitting maxillary denture. METHODS: Institutional review and informed consent were obtained and qualified subjects were randomly assigned to a treatment sequence. Prior to adhesive application, subjects were asked to bite on a transducer with increasing force until their maxillary denture dislodged (bite force measurement). This procedure was repeated at 0.5, 1, 3, 6, 9, and 12 hours after adhesive application, with results recorded electronically. Treatment differences in the area over baseline (AOB) were analyzed using an ANCOVA model. RESULTS: A total of 48 subjects completed the study. All experimental formulations showed statistically significantly higher bite force measurements compared to the No Adhesive arm at all time points (p < 0.0001 for Adhesive 1 and Adhesive 2 at all times; p < 0.003 for Adhesive 3 at all times). While numerical values for bite force favored the Positive control for the duration of the study, there were no significant statistical differences at any time point between Adhesive 2 and the Positive control, and only over three and six hours compared to Adhesive 1. However, differences favored the Positive control compared to Adhesive 3 at all time points. CONCLUSIONS: All denture adhesives gave statistically significantly better bite force AOB in moderately well- to well-fitting dentures compared to no adhesive. All denture adhesives tested were generally well tolerated.

Dental health professional recommendation and consumer habits in denture cleansing.

STATEMENT OF PROBLEM: Regular cleaning of dentures is essential to the oral and general health of denture wearers. Only limited systematic data are available on the recommendations that dental health care professionals (DHCPs) make to patients for denture cleaning. Data on denture wearers' cleaning regimens are also lacking. PURPOSE: The purpose of this study was to provide data on recommendations that DHCPs make to patients for denture cleaning and on the cleaning regimens of denture wearers. MATERIAL AND METHODS: DHCPs (n=613), including dentists and hygienists, were surveyed in developed (Japan, USA, Italy) and developing (Brazil, India) countries. A questionnaire assessing a range of denture cleaning recommendations was used. The questions addressed products, frequency, how to use remedies, the suggested dilution and duration of cleansing treatment, the location of dentures while cleaning, and the reasoning behind the recommendation of particular products or modes of treatment. Denture cleansing methods and the routine of denture wearers in developed and developing countries were also surveyed with a questionnaire (n=2862) and a 1-week diary (n=1462). RESULTS: An average of more than 2 treatments was recommended by DHCPs. Specialist denture cleanser tablets, "regular" toothpaste, mouthwash, soap and water, denture paste, foam or liquid denture cleanser, and dishwashing detergents were most commonly recommended; other product recommendations included baking soda, vinegar, salt water, and bleach. More than 10% of DHCPs made no primary recommendation on cleaning. Denture tablets were more commonly recommended in developed countries, whereas toothpaste was the most common recommendation in developing countries. Denture wearers used products and methods similar to those recommended by DHCPs. Toothpaste, water, and mouthwash were used more frequently than denture tablets. More than 75% of denture wearers reported using denture cleanser tablets for more than 5 minutes, whereas soap and toothpaste were typically used for less than 2 minutes. CONCLUSIONS: DHCP recommendations and denture wearer habits are diverse, with no consensus on the most appropriate denture cleaning methods. This reflects a lack of clear, systematic evidence upon which to base recommendations.