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

Introduction Complete 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. Methods This 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. Results Two patients in the IM-CCD group and one patient in the BPS group were lost to follow-up. Hence only the secondary outcome data were analyzed for these patients. Primary outcome data of patients who were lost to follow-up were excluded from the analysis. No significant differences (p>0.05) were found between the two groups for age and gender characteristics of the samples. Masticatory efficiency for both peanut and carrot was found to be significantly higher (p<0.05) in the BPS group than in the IM-CCD group. No significant differences (p>0.05) in the mean scores were observed between the two groups for total OHIP-EDENT scores or the individual domain scores. No significant differences (p>0.05) were observed between the groups for the number of denture adjustments done. Conclusion Within the limitations of the trial, it can be concluded that the BPS dentures significantly improved the masticatory efficiency for both hard (carrots) and soft (peanuts) foods compared to the IM-CCD. However, there was no difference between the masticatory-related complaints domain scores between the two dentures. No significant differences were found between BPS dentures and IM-CCD with respect to overall patient satisfaction scores or post-insertion denture adjustments.