Two-center clinical trial of implant-retained mandibular overdentures versus complete dentures-chewing ability.

This study is a two-center clinical trial with the aim to assess the treatment effects of implant-retained mandibular overdentures versus conventional complete dentures. Treatment had been assigned according to a balanced allocation method. The following criteria were used to enhance the comparability of the treatment groups: age, gender, the edentulous period of the mandible, the number of previously made mandibular dentures, the number of years having worn the present mandibular denture and the symphyseal bone height. 151 patients with severely resorbed mandibles participated in the study, they were treated at two centers. Ninety-one patients received an implant-retained mandibular overdenture (IRO) and 60 patients a conventional complete denture (CD). Since some patients refused the allocated treatment the "Intention To Treat" principle was applied. This implies that patients are evaluated in the originally allocated treatment group regardless of the actual treatment they received. Patient's experiences were evaluated before treatment and 1 yr after insertion of the new dentures. Results before treatment showed that both treatment groups were comparable: they were dissatisfied with their mandibular denture and they could hardly chew tough or hard foods. One year after insertion of the new dentures the IRO-group was satisfied with their mandibular denture, whereas only one third of the CD-group was satisfied. With respect to the chewing ability the IRO-group scored significantly better than the CD-group(P<0.0001).

RCT Entities:   Population Interventions Outcomes