Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04618900 |
| Other study ID # |
Aalborg University Hospital |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 22, 2019 |
| Est. completion date |
November 1, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Aalborg University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Implant placement in the posterior part of the maxilla is frequently compromised or
impossible due to atrophy of the alveolar process and pneumatisation of the maxillary sinus.
Therefore, alveolar ridge augmentation is frequently necessary before or in conjunction with
implant placement. The most commonly used method to augment the maxillary premolar and molar
region involves the maxillary sinus floor augmentation applying the lateral window technique
with a grafting material. However, the lateral window technique is associated with prolonged
patient treatment time and increased morbidity. Thus, osteotome-mediated sinus floor
elevation (OSFE) with or without the use of a grafting material has been advocated, when the
residual bone height is more than 6 mm.
OSFE involves preparation of implant site through the use of concave osteotomes and elevation
of the maxillary sinus floor. The survival of suprastructure and implants after OSFE with or
without the use of a grafting material has never been assessed in long-term randomized
controlled trials. A long-term study concluded that OSFE with no grafting material is a
predictable treatment modality. High short-term implant survival rates after OSFE with or
without the use of a grafting material have been reported in systematic reviews. However, the
amount of new bone formation after OSFE with the use of a grafting material is significantly
higher compared to the use of no grafting material, as documented in a systematic review.
Harvesting of autogenous bone graft is associated with risk of donor site morbidity and bone
substitutes of natural transplants involves a risk of contamination, activation of host
immune system and disease transmission as well as they can be refused by patients for
religious reasons or because they are in contrast with chosen lifestyle.
Therefore, the objective of the present study is to test the H0-hypothesis of no difference
in the long-term implant treatment outcome after OSFE with Bio-Oss Collagen compared with the
use of no grafting material. A total of 40 consecutively healthy patients with a missing
posterior tooth in the maxilla will be allocated at random to OSFE with Bio-Oss Collagen or
no grafting material and simultaneous implant placement. Clinical and/or radiographical
evaluation using periapical radiographs and Cone Beam Computer Tomography (CBCT) will be
performed preoperatively, immediate postoperatively, after abutment connection, after
prosthetic rehabilitation, one year, three years and five years after loading to assess the
long-term implant treatment outcome and the volumetric changes of the augmented area. The
primary outcome will include survival of suprastructures, survival of implants, volumetric
stability of the augmented area, peri-implant marginal bone level, oral health related
quality of life, and complications related to the two treatment modalities.
Description:
Implant placement in the posterior part of the maxilla is frequently compromised or
impossible due to atrophy of the alveolar process and pneumatisation of the maxillary sinus.
Therefore, alveolar ridge augmentation is frequently necessary before or in conjunction with
implant placement. The most commonly used method to augment the maxillary premolar and molar
region involves the maxillary sinus floor augmentation applying the lateral window technique
with autogenous bone graft or bone substitutes and the treatment outcome has been reported in
systematic reviews. However, maxillary sinus floor augmentation with the lateral window
technique and bone harvesting is associated with prolonged patient treatment time and risk of
donor site morbidity. Hence, OSFE with or without the use of a grafting material is commonly
used to simplify the surgical procedure, when the residual alveolar bone height is more than
6 mm.
OSFE with simultaneous implant placement was originally described by Summers in 1994. The
surgical procedure involves a transalveolar up-fracture and elevation of the maxillary sinus
floor and Schneiderian membrane using concave osteotomes. Implants are inserted
simultaneously to support the elevated floor of the maxillary sinus. The created compartment
between the elevated floor of the maxillary sinus and the original sinus floor is filled with
either particulated autogenous bone graft, a bone substitute or without a grafting material.
The final implant treatment outcome after OSFE with or without the use of a grafting material
have previous been assessed in systematic reviews and meta-analyses disclosing high implant
survival rates with few complications. However, the included studies are often characterized
by a moderate to high risk of bias and the conclusions are based on short-term non-randomized
controlled trials, whereas long-term randomized controlled trials assessing OSFE with or
without the use of a grafting material is sparse.
OSFE with autogenous bone graft or a bone substitute is considered the golden standard and
the gain in alveolar bone height is enhanced with the use of a grafting material compared to
the use of no grafting material. Bio-Oss (Geistlich Pharma AG, Wolhusen, Switzerland) is a
deproteinized bone substitute of bovine bone origin and several studies have documented that
Bio-Oss possesses important properties when used as a membrane-supporting material and as a
scaffold for in-growth of host cells including biocompatibility and osteoconductivity.
Bio-Oss has been used for different bone augmentation procedures for more than 30 years and
OSFE with Bio-Oss is a safe and very predictable surgical procedure with few complications
and minimal morbidity, as documented in systematic reviews and long-term studies. However,
bone substitutes of natural transplants involves a risk of contamination, activation of host
immune system and disease transmission as well as they can be refused by patients for
religious reasons or because they are in contrast with chosen lifestyle. Thus, OSFE without a
grafting material is associated with obvious advantages for the patient, including reduced
risk of infection, less cost, reduced length of operation time and no risk of disease
transmission.
Survival of suprastructures and implants are the most important measures for the assessment
of the long-term implant treatment outcome. However, long-term survival of suprastructures
after OSFE with or without the use of a grafting material has never been compared within a
randomized controlled trial. Moreover, patient-reported outcome measures after OSFE have
never previously been assessed. A long-term randomized controlled trial revealed no
significant differences in implant survival after OSFE with Bio-Oss compared with the use of
no grafting material after five years. A newly published systematic review and meta-analysis
disclosed no significant differences in the short-term implant survival after OSFE with or
without the use of a grafting material and a long-term retrospective study assessing OSFE
without the use of a grafting material reported an implant survival rate 97.7% after 15
years. Moreover, long-term studies assessing OSFE without a graft material revealed high
implant survival after 10 years.
In conclusion, OSFE without the use of a grafting material seems to be a predictable
treatment modality with high implant survival. However, the long-term survival of
suprastructure and implants after OSFE with or without the use of a graft material is
presently not sufficient clarified and has not been assessed in long-term randomized trial.
