Survival, ProsthesisNCT04618900
Osteotome-mediated Sinus Floor Elevation With or Without Grafting Material
A study testing Sinus floor elevation with a grafting material in people with Survival, Prosthesis and Bone Loss, run by Aalborg University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Survival, Prosthesis, Bone Loss, Patient Satisfaction
- What is being tested?
- Sinus floor elevation with a grafting material
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Nov 2019to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and females of ≥20 years of age.
- Missing one posterior maxillary tooth (premolar or molar) for more than 4 months.
- Residual vertical alveolar bone height of the maxillary alveolar process ≤ 6-10mm ≤.
- Width of the alveolar maxillary process ≥6.5 mm.
- Mandibular occluding teeth.
- Should be able to speak and understand Danish.
Who cannot join
- Medical contraindications to implant therapy e.g. recent myocardial infarction and cerebrovascular accident, recent valvular prosthesis surgery, immunosuppression, bleeding issues, active treatment of malignancy, drug abuse, psychiatric illness and intravenous bisphosphonate treatment.
- Irradiated jaw bones (radiotherapy treatment).
- Full mouth plaque score >25%.
- Progressive marginal periodontitis in the maxilla and mandible.
- Acute infection in the area intended for implant placement.
- Parafunction, bruxism, or clenching.
Show all 9Show fewer
- Psychiatric problems or unrealistic expectations.
- Heavy tobacco use, define as >10 cigarettes per day.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteotome-mediated Sinus Floor Elevation With Bio-Oss Collagen Compared With the Use of no Grafting Material. A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Survival, Prosthesis, Bone Loss, Patient Satisfaction
- Being tested
- Sinus floor elevation with a grafting material
- Keywords
- Alveolar ridge augmentation, Maxillary sinus floor elevation, Bone substitute
- Medical subject headings
- Prosthesis Failure, Bone Diseases, Metabolic, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus floor elevation with a grafting materialProcedure or surgery
The use of grafting material for sinus floor elevation
| Study group | Role | What they receive |
|---|---|---|
| Osteotome-mediated sinus floor elevation with Bio-Oss collagen | Experimental | Sinus floor elevation with a grafting material (Bio-Oss collagen) Receives: Procedure: Sinus floor elevation with a grafting material |
| Osteotome-mediated sinus floor elevation with no grafting material | Placebo comparator | Sinus floor elevation with no grafting material Receives: Procedure: Sinus floor elevation with a grafting material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of suprastructures and implants
Loss of suprastructures and dental implants
Measured: 1-year
Secondary outcomes (1)
Volumetric stability of the grafting material
Radiographic loss of the augmented area
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start22 Nov 2019
- Primary completion1 Apr 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Survival, ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Starch-Jensen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618900
- Sponsor's protocol ID
- Aalborg University Hospital
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers
Publications
Starch-Jensen T, Bruun NH, Spin-Neto R. Endo-sinus bone gain following osteotome-mediated sinus floor elevation with Bio-Oss Collagen compared with no grafting material: a one-year single-blind randomized controlled trial. Int J Oral Maxillofac Surg. 2023 Nov;52(11):1205-1215. doi: 10.1016/j.ijom.2023.03.009. Epub 2023 Mar 29.
PubMed 36997448
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteotome-mediated Sinus Floor Elevation With Bio-Oss Collagen Compared With the Use of no Grafting Material. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04618900
- Acronym / sponsor ID
- Aalborg University Hospital
- Conditions
- Survival, Prosthesis, Bone Loss, Patient Satisfaction
- Keywords
- Alveolar ridge augmentation, Maxillary sinus floor elevation, Bone substitute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Osteotome-mediated sinus floor elevation with Bio-Oss collagen | Experimental | Procedure: Sinus floor elevation with a grafting materialSinus floor elevation with a grafting material (Bio-Oss collagen) |
| Osteotome-mediated sinus floor elevation with no grafting material | Placebo comparator | Procedure: Sinus floor elevation with a grafting materialSinus floor elevation with no grafting material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and females of ≥20 years of age.
- Missing one posterior maxillary tooth (premolar or molar) for more than 4 months.
- Residual vertical alveolar bone height of the maxillary alveolar process ≤ 6-10mm ≤.
- Width of the alveolar maxillary process ≥6.5 mm.
- Mandibular occluding teeth.
Key exclusion criteria (9 listed)
- Medical contraindications to implant therapy e.g. recent myocardial infarction and cerebrovascular accident, recent valvular prosthesis surgery, immunosuppression, bleeding issues, active treatment of malignancy, drug abuse, psychiatric illness and intravenous bisphosphonate treatment.
- Irradiated jaw bones (radiotherapy treatment).
- Full mouth plaque score >25%.
- Progressive marginal periodontitis in the maxilla and mandible.
- Acute infection in the area intended for implant placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinus floor elevation with a grafting materialThe use of grafting material for sinus floor elevation | Procedure or surgery | Osteotome-mediated sinus floor elevation with Bio-Oss collagen, Osteotome-mediated sinus floor elevation with no grafting material |
Primary outcome
Survival of suprastructures and implants
Time frame: 1-year
Loss of suprastructures and dental implants
1 secondary outcome
Volumetric stability of the grafting material
Time frame: 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 36997448Starch-Jensen T, Bruun NH, Spin-Neto R. Endo-sinus bone gain following osteotome-mediated sinus floor elevation with Bio-Oss Collagen compared with no grafting material: a one-year single-blind randomized controlled trial. Int J Oral Maxillofac Surg. 2023 Nov;52(11):1205-1215. doi: 10.1016/j.ijom.2023.03.009. Epub 2023 Mar 29.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinus floor elevation with a grafting material in people with Survival, Prosthesis and Bone Loss, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of suprastructures and implants (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04618900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.