Randomized controlled clinical trial for verifying effects of complete dentures with the resilient denture liner on edentulous patients

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A randomized controlled parallel clinical trial at the two hospitals was conducted from April 2004 to July 2006. The permuted block method of randomization with a block size of four consisting of,. treatment with RLD by a senior clinician (SC), treatment with RLD by a junior clinician (JC), treatment with ARD by a SC and treatment with ARD by a JC, in a combination of treatments and clinicians groups (treatments=ARD and RLD ; clinicians=JC and SC) was used. Outcomes: a) numbers of sore spots ; b) duration of wearing dentures; c) pain perception ; d) satisfaction ratings; e) masticatory performance ; f) mandibular movement at the lower incisal point during chewing Results Seventy-four patients who had been consecutively sampled (aged 53 to 89 yrs) were randomized for this trial. No significant differences were observed in any of the baseline characteristics between the ARD and RLD. Significant differences in the number of sore spots in the support and border areas for the mandibular mucosa were clearly observed between the RLD and ARD groups. In contrast, there were no differences in the number of sore spots in the frenum area. Furthermore, significant differences in the number of sore spots in the support and border areas for the maxillary mucosa were definitely observed between the JC and SC groups. The RLD wearers were able to wear their dentures an additional day longer than the ARD wearers. Significant differences between the RLD and ARD groups in the maxillary and mandibular pain ratings were observed. There was no significant difference in the masticatory performance and mandibular movement at the lower incisal point during chewing between the ARD and RLD groups.