Outcomes following osteotome-mediated sinus floor elevation with Bio-Oss Collagen or no grafting material: a one-year single-blind randomized controlled trial

Abstract

The objective of this single-blind randomized controlled trial was to test the hypothesis of no difference in implant treatment outcome and patient-reported outcome measures (PROMs) following osteotome-mediated sinus floor elevation with Bio-Oss Collagen (test) compared with no grafting material (control) after 1 year of implant loading. Forty healthy patients (27 female, 13 male) with a mean age of 49 years (range 24–74 years) were randomly allocated to the test or control group. Outcome measures included survival of the suprastructures and implants, peri-implant marginal bone loss, complications, and PROMs; the latter included the Oral Health Impact Profile-14 and a self-administered questionnaire with visual analogue scales to assess the peri-implant tissue, implant crown, function of the implant, total implant treatment outcome, and oral health-related quality of life. Mean differences were expressed with the standard deviation and 95% confidence interval. The level of significance was 0.05. Survival of the suprastructures and implants was 100% with both treatment modalities. No significant difference in any of the outcome measures was observed between the test and control groups. High patient satisfaction and a significant improvement in quality of life were observed with both treatment modalities. Consequently, no significant difference in implant treatment outcome between the test and control groups was revealed after 1 year of implant loading. Neither of the treatment modalities can therefore be considered better than the other.