Methods
dry dentures, edentulous, Denture, denture adhesives, tooth, denture
This study was designed as a randomized, single-blind, clinical trial. The study was conducted in accordance with the World Medical Declaration of Helsinki and conformed to the Consolidated Standards of Reporting Trials (CONSORT) statement for randomized clinical trials [All participants were completely edentulous patients seeking new complete dentures at the prosthodontics specialty clinics at a University Hospital. Only participants with normal alveolar ridge volume and resilience were included [Inclusion CriteriaThe fabrication of all dentures was performed by 2 experienced prosthodontists (N.E., Y.O.) and laboratory steps were performed by an experienced dental laboratory technician. After the primary impressions were made from impression compound modeling plastic material (Impression Compound; Kerr Corp., Orange, CA), they were sent to the dental laboratory where they were poured using Type III dental stone (Microstone; Whip Mix Corp., Louisville, KY) to produce preliminary casts, on which custom trays were fabricated from light-polymerizing resin sheets (Vertex Light Curing Trayplates; Vertex-Dental, Zeist, Netherlands). Custom trays were consequently border molded using impression compound modeling plastic (Kemco Tracing Sticks Green; Kemdent, Swindon, UK), and used for taking definitive impressions by using zinc oxide eugenol (Outline; Cavex, Haarlem, Netherlands). The impressions were then used to produce master casts on which record bases (Vertex Light Curing Trayplates, Vertex-Dental, Zeist, Netherlands) and wax occlusal rims (Cavex Set Up Regular Modeling Wax; Cavex, Haarlem, Netherlands) were fabricated which were later used for recording the maxillomandibular relationship. The casts were then mounted on an average value articulator (Gysi simplex OU-H3; COMATSU, Saitama, Japan), and tooth arrangement was done accordingly. After the clinical evaluation of the waxed dentures, they were sent to the dental laboratory where they were then flasked (Hanau Flask and Compress; Pearson Dental Supply Co, Sylmar, CA) and processed with heat-polymerizing acrylic resin (Lucitone 199; Dentsply Sirona, York, PA). After finishing and polishing of the dentures, they were then delivered and participants were given review appointments for post-delivery adjustments until the participants reported no further complaints. Participants were then given a review appointment after 1 month.At the review appointments, after using the dentures for a month with no denture adhesives, the participants evaluated their satisfaction with the dentures on a horizontal 100- mm VAS based on the criteria suggested by Celebic and Knezovic-Zlataric [Participants were subsequently given 1 type of denture adhesives according to the allocated group found in the sealed envelope. The C group received Corega Ultra denture adhesive (GlaxoSmithKline Brazil Ltda., Rio de Janeiro, Brazil), the O group received OlivaFix denture adhesive Cream (Bonyf, Heiligkreuz 16, Vaduz, Liechtenstein) and S group received Sea.bond denture adhesive seals (Sea.Bond, White planes, NY, USA). Adhesives used and their composition are shown in Table Denture adhesive materials used in this study, their manufacturers and compositionParticipants were given instructions for using and cleaning the denture adhesives. Participants in group C were instructed to apply the adhesive on clean and dry dentures, once a day, away from the edges as shown in the diagram on the adhesive package, rinse mouth before use, press dentures in place firmly and bite down for few seconds to secure hold. For adhesive removal, participants were instructed to remove the adhesive using warm water and soft brush and use COREGA Cleanser (GlaxoSmithKline Brazil Ltda., Rio de Janeiro, Brazil) for more thorough cleaning.Participants in group O were given similar instructions, according to the leaflet provided with the adhesive and were instructed to clean mouth and dentures properly if adhesive residues remain using a clean paper towel. Participants in group S were instructed to place dry Sea. Bond seals, white side up, onto clean dry dentures, trim any overlap with scissors, lightly moisten and gently tap seal with fingertips, put denture in mouth and bite down evenly for 5 seconds. Participants were instructed to remove the seal at the end of the day by lifting the corner and peeling it away and to change seals daily. During the month of using the adhesive, weekly phone calls were made to each participants to ensure their compliance with the instructions provided.. All participants were finally reviewed after 1 month to fill out the same forms again.Dentists who performed this study were blinded to which type of denture adhesive was given to the participants. Data collection was done by a dentist who did not participate in the treatment and was unaware of the allocated groups. A total of 60 participants were needed to detect a difference of 10 mm on the 100-mm VAS with 90% power (a = .05). To compensate for potential dropouts, 73 patients were originally included in the study, among which 9 were lost after they were given the denture adhesives. 64 participants were eventually included, with C group = 20, O group = 22, and S group = 22. This is illustrated in the flow chart in Fig. Study flowchart showing the numbers of participants in each group during the different stages of the studyStatistical analyses were conducted by using a statistical software package (IBM SPSS Statistics, v22.0; IBM Corp). The data were inspected for normality by using the Kolmogorov-Smirnov and Shapiro-Wilk tests, and the results indicated that both VAS data and OHIP-EDENT were not normally distributed (