Single mandibular implant study (SMIS) - masticatory performance - results from a randomized clinical trial using two different loading protocols

OBJECTIVES: This multi-centre randomized controlled trial was conducted to investigate, whether the masticatory performance of elderly edentulous patients is improved by placement of a single implant in the midline of the edentulous mandible, and whether improvements differ with respect to the loading protocol, i.e., implant is loaded either directly or three months later after second stage surgery.

METHODS: Edentulous seniors aged 60-89 years were screened according to inclusion and exclusion criteria and 163 underwent implant placement. Of those, 158 were randomly assigned either to the direct loading group A (n=81) or the conventional loading group B (n=77). Chewing efficacy was obtained before treatment, one month after implant placement during the submerged healing phase (only group B) and 1 and 4 months after implant loading.

RESULTS: The masticatory performance increased over time in both groups. Four months after loading, a significant increase was observed for both groups compared to the baseline data without implant (p≤0.05). However, between the two groups, chewing efficiency did not differ significantly at any point in time (p>0.05).

CONCLUSIONS: A single midline implant in the edentulous mandible increases masticatory performance significantly, independently from the loading protocol.

CLINICAL SIGNIFICANCE: A single midline implant in the edentulous mandible increases masticatory performance. The loading protocol has no influence.