Abstract
Since few clinical trials have been carried out for permanent soft denture liners, clinicians do not have sufficient evidence of their use. This study investigated the efficacy of applying a permanent soft lining material in a clinical setting.
Methods: Twenty-eight edentulous patients who visited the Nihon University School of Dentistry at Matsudo Affiliated Dental Hospital and who fulfilled the selection criteria and accepted informed consent were enrolled in this trial. The study design was a randomized controlled clinical trial with two-period cross-over. Intervention was conventional denture treatment for both maxilla and mandible in one arm, and conventional denture for maxilla and mandible denture with soft lining material (Sofreliner MS, Tokuyama) in the other arm. The random-permuted-block-within-strata method was used for allocating the subjects into two groups. One group received a conventional denture in both jaws followed by maxilla conventional denture and mandible soft-lined denture, and the other received two sets of denture in contrary order. Outcomes were masticatory performance, number of visits for denture adjustment and preference of fabricated denture. Statistical as well as ITT (Intention to treat) analyses were performed.
Results: 1. Masticatory performance with soft-lined denture was significantly higher than the conventional denture at two and three months after completing adjustments of the denture. 2. The number of visits for denture adjustment with the soft-lined denture was significantly lower than that with the conventional denture. 3. Seventy-two percent of subjects selected the soft-lined denture.
Conclusions: Application of a permanent soft lining material to mandible complete dentures resulted in an improvement in masticatory performance and fewer visits for denture adjustment. Moreover, the majority of subjects selected the soft-lined denture.
