Comparison of Masticatory Efficiency and Patient Satisfaction of Injection-Molded Conventional Complete Dentures and Biofunctional Prosthetic System Dentures: A Parallel Randomized Clinical Trial

Abstract

IntroductionComplete loss of natural teeth severely compromises the masticatory efficiency of geriatric patients and directly affects their general health. Biofunctional prosthetic system (BPS) has been developed as an alternate method of denture fabrication to match the higher expectations of patients. Studies comparing BPS dentures with injection-molded conventional complete dentures (IM-CCD) are lacking. Our study aimed to compare the masticatory efficiency and patient satisfaction of BPS dentures with IM-CCD. MethodsThis trial was designed as a randomized, prospective, single-center, double-blinded study with two parallel arms (BPS group and IM-CCD group) having an equal allocation (1:1). Completely edentulous patients aged 45-80 who visited our outpatient department between January and August 2018 were screened and enrolled according to our inclusion and exclusion criteria. Random sequence generation was done using an online randomization program. Allocation concealment was done using sequentially labeled opaque envelopes. The participants and the outcome assessors were blinded. A single operator performed all the clinical procedures in both groups under the guidance of the instructor. The age and gender of the patients were recorded for demographic data at baseline. Primary outcomes were assessed six weeks after denture insertion. The number of denture adjustments required during the first six weeks after denture delivery was recorded as the secondary outcome. Masticatory efficiency was evaluated by the volumetric single-sieve method. An abbreviated version of the Oral Health Impact Profile questionnaire for edentulous patients (OHIP-EDENT) was used for patient satisfaction scores. The total OHIP-EDENT score was calculated by adding all the responses to the 19 questions (ranging from 0 to 38). Individual domain scores were calculated by adding the response to all the questions in that domain. All the data obtained were tested for normality using the Kolmogorov-Smirnov test. Data were analyzed using either unpaired Student's T-test or Mann-Whitney U test for normal and non-normal data, respectively. The gender characteristics of the sample were compared using Chi-Square test.