TY - JOUR
T1 - Outcomes following osteotome-mediated sinus floor elevation with Bio-Oss Collagen or no grafting material
T2 - a one-year single-blind randomized controlled trial
AU - Starch-Jensen, T.
AU - Bruun, N. H.
AU - Spin-Neto, R.
N1 - Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
PY - 2023/9
Y1 - 2023/9
N2 - 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.
AB - 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.
KW - Alveolar ridge augmentation
KW - Dental implants
KW - Health care surveys
KW - Maxilla
KW - Quality of life
KW - Randomized controlled trial
KW - Sinus floor augmentation
UR - http://www.scopus.com/inward/record.url?scp=85146261940&partnerID=8YFLogxK
U2 - 10.1016/j.ijom.2022.12.009
DO - 10.1016/j.ijom.2022.12.009
M3 - Journal article
C2 - 36639342
SN - 0901-5027
VL - 52
SP - 988
EP - 997
JO - International Journal of Oral and Maxillofacial Surgery
JF - International Journal of Oral and Maxillofacial Surgery
IS - 9
ER -