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.
Keywords
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Article info
Publication history
Published online: January 11, 2023
Accepted:
December 21,
2022
Publication stage
In Press Corrected ProofIdentification
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© 2023 The Author(s). Published by Elsevier Inc. on behalf of International Association of Oral and Maxillofacial Surgeons.
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