Stabilizing mandibular complete dentures by a single midline implant-influence on quality of life: 2-year results from a randomized clinical trial comparing different loading protocols

OBJECTIVES: The knowledge about the influence of dental treatment on health-related quality of life (HRQoL) is still limited. The aim of this multicenter randomized controlled clinical trial was to assess the effect of stabilizing an existing complete denture, by means of a single mandibular implant, on HRQoL. Furthermore, the impact of the loading protocol, i.e., immediate or delayed loading, in edentulous patients was evaluated.

METHODS: One hundred fifty-eight participants aged 60-89 years were randomly assigned to study group A (immediate loading; n = 81) and to group B (delayed loading; n = 78). All participants received a single midline implant in the mandible. The implants were either immediately loaded (group A) or after a closed healing period of 3 months (group B) by connecting the existing mandibular complete dentures to ball attachments. HRQoL was assessed with the Short Form-36 questionnaire of health (SF-36) at baseline, 4 months, and 24 months after implant loading.

RESULTS: Improvement of HRQoL by means of a single implant-retained mandibular overdenture could not be demonstrated after 4 and 24 months of implant loading. Furthermore, the application of two different loading protocols did not influence HRQoL ratings of study participants.

CONCLUSION: The loading protocol is not a factor, influencing HRQoL in patients treated by a single midline implant in the edentulous mandible.

CLINICAL RELEVANCE: A single midline implant in the edentulous mandible, stabilizing a mandibular complete denture, cannot be recommended for improving HRQoL.