Effect of denture adhesives on masticatory performance: Multicenter randomized controlled trial.

PURPOSE: The purpose of this study is to investigate the effects of denture adhesives on masticatory performance via a 10-center, parallel, randomized, controlled trial of complete denture wearers in Japan. METHODS: The trial was conducted between September 2013 and October 2016. The inclusion criteria were complete edentulism, willingness to undergo new complete denture treatment, and willingness to return for recall treatment. The exclusion criteria were age 90 years or older, presence of severe systemic illness, inability to understand the questionnaires, wearing metal base complete dentures, denture adhesive user, wearing prosthetics for maxillofacial defects, wearing complete dentures with tissue conditioners, and severe xerostomia. Randomization of the powder-type denture adhesive (powder), cream-type denture adhesive (cream), and control (saline) groups was performed using a sealed envelope system. Masticatory performance was measured using color-changeable chewing gum. Intervention blinding was not feasible. RESULTS: Sixty-seven control, 69 powder, and 64 cream participants are analyzed using the intention-to-treat principle. The participants in all groups show significantly improved masticatory performance at post-intervention (paired t-test with Bonferroni correction P < 0.0001). However, no significant difference in masticatory performance is detected among the three groups (one-way analysis of variance). A significant negative correlation between pre- and post-changes in masticatory performance and intraoral condition scores is observed (Pearson's correlation coefficient, P < 0.0001). CONCLUSIONS: Although denture adhesives improved the masticatory performance of complete denture wearers, their clinical effects are comparable to those of saline solution. The use of denture adhesives is more effective in complete denture wearers with unsatisfactory intraoral conditions.

Effects of denture adhesives on denture retention and occlusal forces in complete denture wearers: A multicenter, randomized controlled trial.

PURPOSE: This study aimed to determine the effects of denture adhesives on denture retention and occlusal force in complete denture wearers in a multicenter, randomized, parallel-group controlled trial. METHODS: Two hundred edentulous patients wearing complete dentures were allocated to three groups: powder-type denture adhesive, cream-type denture adhesive, and control (saline solution). Denture adhesives and saline solution were applied to the dentures for 4 days. The retentive force of the dentures and occlusal force were measured using a force transducer occlusal force meter at baseline and after 4 days of intervention. In addition to between-group comparisons, subgroup analyses of denture retention and occlusal force were performed based on the level of difficulty of the edentulism treatment. The levels were ranked as I (easy), II, III, and IV (difficult). RESULTS: Cream-type denture adhesives significantly improved the retentive force of the dentures (P<0.01) and occlusal force (P<0.05), with no significant differences between baseline and post-intervention forces in the powder-type denture adhesive and control groups. In within-group comparisons, cream-type denture adhesives improved both the retentive and occlusal forces at Level II (P<0.05), and powder-type denture adhesives improved the occlusal force at Level II (P<0.01). CONCLUSIONS: Application of cream-type denture adhesives effectively improves the denture retention and occlusal force in complete denture wearers with a moderate degree of difficulty during edentulism treatment.

Clinical efficacy of mandibular complete dentures with a resilient liner: study protocol for a multicenter randomized controlled trial.

BACKGROUND: During restoration of poorly fitting complete dentures (CDs) in edentulous patients, liners are used to reconstruct the concave surfaces of CDs with a new base material. These relining materials are classified into resilient liners (RLs) and non-resilient liners (NRLs), but the clinical effects of these liners and their selection criteria remain unclear. The purpose of this study is to evaluate the clinical efficacy of relining mandibular CDs using RL and NRL and to conduct a follow-up study. METHODS: The study is currently being conducted at eight centers, and a parallel-group randomized controlled trial (RCT) is underway. One hundred thirty-two edentulous patients with poorly fitting mandibular CDs will be assigned to two groups based on whether they will receive RL or NRL. Participants will have an RL or NRL applied for relining their CDs using an indirect method of dynamic impressions. Data will be recorded at 1 week and 3, 6, and 12 months after denture delivery. The primary outcome will be assessment of the patients' general satisfaction by using a 100-mm visual analog scale (VAS). Secondary outcomes will be measured as patient-reported outcomes, including food intake status and oral hygiene-related quality of life. Masticatory performance and the number of sore spots on the oral mucosa will also be recorded. Comparisons between the two groups and within-subject comparisons of pre- and post-intervention measurements will be conducted. DISCUSSION: For dentists and prosthetic researchers in Japan, this RCT will provide information on the clinical efficacy of RL materials in comparison to RNL in CD wearers. The new evidence regarding the use of RL materials in an aging population will also be useful to dentists in other countries in their routine clinical practice. TRIAL REGISTRATION: This clinical trial has been registered at the University Hospital Medical Information Network (UMIN) Center (UMIN000041950).

Intranasal calcitonin gene-related peptide administration impairs fear memory retention in mice through the PKD/p-HDAC5/Npas4 pathway.

The calcitonin gene-related peptide (CGRP) suppresses fear memory retention in mice. Although intracerebroventricular administration of CGRP alters the fear memory processes, making it a promising therapeutic strategy for post-traumatic stress disorder (PTSD), direct brain injection into patients is not practical. Therefore, we propose that intranasal application may be an effective way to deliver CGRP to the brain. This study tested whether CGRP nasal administration exerts the same effect as intracerebroventricular administration using C57BL6J mice. The amount of CGRP in the cerebrospinal fluid and hippocampus 30 min after nasal administration of CGRP was significantly higher when compared with saline. Intranasal CGRP also elicited photophobic behaviors similar to intracerebroventricular injection. Moreover, intranasal CGRP decreased fear memory retention but did not affect reactivation and extinction of fear memory. We found intranasal CGRP significantly increased the expression of protein kinase D (PKD), phosphorylated histone deacetylase 5 (p-HDAC5) and neuronal PAS domain protein 4 (Npas4) in the hippocampus. CGRP-mediated impairment of fear memory and Npas4 expression increases were attenuated significantly by the CGRP receptor antagonist BIBN4096. Together, our data demonstrate that intranasal CGRP delivery activates the PKD/p-HDAC5/Npas4 pathway, decreases fear memory retention.

Multivariate analysis reveals oral health-related quality of life of complete denture wearers with denture adhesives: a multicenter randomized controlled trial.

Purpose To investigate the difference in improvement of oral health-related quality of life (OHR-QoL) depending on the oral and denture conditions of a complete denture wearer when using a cream or powder type denture adhesive in a 10-center parallel randomized clinical trial.Methods Two hundred edentulous subjects who wore complete dentures were allocated to each of the three groups according to denture adhesive type: cream, powder, and control (saline solution). The materials were applied to the mucosal surface of the dentures for 4 days, and baseline data and data after the intervention were collected. OHR-QoL was assessed using the Japanese version of the modified Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-J) scale for outcome. Multivariate analysis was used to investigate improvements in OHR-QoL according to participant characteristics among complete denture wearers using these materials.Results OHIP-EDENT-J scores were significantly decreased in all groups after the intervention (p < 0.05); however, there were no statistically significant differences among the groups. Multiple logistic regression analysis revealed a significant association between the vertical height of the maxillary and mandibular alveolar ridge and OHIP-EDENT-J scores in the cream-type denture adhesive group. In contrast, there were no significant association between participant characteristics and OHIP-EDENT-J scores in the powder-type adhesive and control groups.Conclusions The use of denture adhesives could improve OHR-QoL for complete denture wearers. The cream-type denture adhesives may be expected to improve OHR-QoL in patients with poor residual ridge conditions compared with patients with good residual ridge conditions.

Effect of denture adhesives on oral moisture: A multicenter randomized controlled trial.

PURPOSE: The purpose of this study was to investigate the effect of denture adhesives on oral moisture in a 10-center parallel randomized clinical trial. METHODS: Two hundred edentulous subjects wearing complete dentures were allocated into three groups: cream-type adhesive, powder-type adhesive and control groups. The adhesives (and saline solution in the control group) were applied to the mucosal surface of the dentures for 4 days, and baseline data and data after the intervention for eight meals over 4 days were obtained. For the main outcome, oral moisture was measured with a moisture checking device. Secondary outcomes were denture satisfaction, masticatory performance, denture retention, and occlusal force. In addition to between-group and within-group comparisons of oral moisture, investigations for secondary outcomes were undertaken in subgroups classified according to the degree of oral moisture at baseline (normal subgroup and dry mouth subgroup). Intention-to-treat analysis was also performed. RESULTS: Between-group and within-group comparisons of oral moisture showed no significant differences. The cream-type and powder-type denture adhesives were significantly effective in the dry mouth group for denture satisfaction ratings of ability to masticate, stability, retention, and comfort of mandibular dentures (p<0.05). The masticatory performance and retentive force of the dry mouth denture adhesive using groups were significantly improved after intervention (p<0.05). CONCLUSIONS: The oral moisture of complete denture wearers was not influenced by the use of denture adhesives. Our findings showed that denture adhesives improved subjective denture satisfaction, masticatory performance, and retention for complete denture patients with oral dryness.

Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial.

BACKGROUND: Denture adhesives, characterized as medical products in 1935 by the American Dental Association, have been considered useful adjuncts for improving denture retention and stability. However, many dentists in Japan are hesitant to acknowledge denture adhesives in daily practice because of the stereotype that dentures should be inherently stable, without the aid of adhesives. The aim of this study is to verify the efficacy of denture adhesives to establish guidelines for Japanese users. The null hypothesis is that the application of denture adhesives, including the cream and powder types, or a control (isotonic sodium chloride solution) would not produce different outcomes nor would they differentially improve the set outcomes between baseline and day 4 post-application. METHODS: This ten-center, randomized controlled trial with parallel groups is ongoing. Three hundred edentulous patients with complete dentures will be allocated to three groups (cream-type adhesive, powder-type adhesive, and control groups). The participants will wear their dentures with the denture adhesive for 4 days, including during eight meals (three breakfasts, two lunches, and three dinners). The baseline measurements and final measurements for the denture adhesives will be performed on the first day and after breakfast on the fourth day. The primary outcome is a general satisfaction rating for the denture. The secondary outcomes are denture satisfaction ratings for various denture functions, occlusal bite force, resistance to dislodgement, masticatory performance, perceived chewing ability, and oral health-related quality of life. Between-subjects comparisons among the three groups and within-subjects comparisons of the pre- and post-intervention measurements will be performed. Furthermore, a multiple regression analysis will be performed. The main analyses will be based on the intention-to-treat principle. A sample size of 100 subjects per group, including an assumed dropout rate of 10 %, will be required to achieve 80 % power with a 5 % alpha level. DISCUSSION: This randomized clinical trial will provide information about denture adhesives to complete denture wearers, prosthodontic educators, and dentists in Japan. We believe this new evidence on denture adhesive use from Japan will aid dentists in their daily practice even in other countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT01712802 . Registered on 17 October 2012.

Influence of Occlusal Force on Electroencephalograms in Edentulous Patients.

PURPOSE: This study explored the effect of improved occlusal force resulting from complete denture treatment on electroencephalogram (EEG) findings to determine if such an outcome is a factor contributing to activation of synaptic/neuronal dysfunction in the brain. MATERIALS AND METHODS: Twenty-three individuals with complete upper and lower dentures who visited the Department of Removable Prosthodontics at Tsurumi University Dental Hospital were included in this study. The Dental Prescale Occluzer FPD-705 system was used to perform an objective measurement of occlusal force before and after denture treatment. EEGs were recorded for 3 minutes in patients receiving complete dentures before and after denture treatment. Then, Dα values were calculated using a diagnosis method of neuronal dysfunction analysis to evaluate changes in synaptic/neuronal dysfunction of the brain. To investigate whether occlusal force affects Dα, Spearman's rank correlation coefficient (α = 0.05) was used to test the association between occlusal force (N) and Dα based on the rates of change in occlusal force and Dα calculated by dividing the measurement values after denture treatment by the measurement values before denture treatment. RESULTS: Medial occlusal force increased from 184.9 N before treatment to 277.2 N after treatment. A statistically significant increase in occlusal force (p < 0.05) was observed, with a total of 22 participants exhibiting increased occlusal force after denture treatment. The medial Dα value increased from 0.943 before treatment to 0.957 after treatment. A statistically significant increase in Dα (p < 0.05) was observed, and a total of 19 participants exhibited increased Dα values after denture treatment. The regression line was calculated as Y = 14.049X - 12.450. As occlusal force increased, Dα values increased as well. A significant positive correlation was observed between occlusal force and Dα (r = 0.498, p < 0.05). CONCLUSIONS: A positive correlation was observed between improved occlusal force attained via complete denture treatment and the activation of Dα. This finding reveals occlusal force as a denture treatment outcome that contributes to the activation of synaptic/neuronal dysfunction in the brain.

Influence of vertical dimension of occlusion changes on the electroencephalograms of complete denture wearers.

PURPOSE: The present study was conducted to identify how changes in the vertical dimension of occlusion (VDO) affect the sensory perception and activity of the brain in complete denture wearers using an electroencephalogram (EEG). METHODS: Subjects were 21 individuals wearing complete dentures who regularly visited the Division of Prosthodontics at Tsurumi University Dental Hospital for checkups (12 males and 9 females, average age: 76.6). Based on their original dentures, two duplicate dentures with different VDO (-3mm and +5mm) were fabricated. EEG activity and occlusal force were measured before and after gum chewing with each denture in all subjects. Negative indicator scores for psychological conditions and stable neuronal activity (Dα) were calculated using EEG data. Statistical analysis was performed using the Wilcoxon test to compare changes in the sensory perception, activity of the brain, and occlusal force (α=0.05). RESULTS: After gum chewing with the +5-mm denture, a significant increase was observed in the negative indicator score (p<0.05). No significant difference was found in the Dα values before and after gum chewing with any of the dentures (p>0.05). A significant decrease was observed in the occlusal force between the original denture and the -3-mm denture (p<0.05). CONCLUSION: Psychological condition and occlusal force were influenced by immediate changes in the VDO of the complete denture.