Bone LossNCT04581304
The Use of Bio-Oss Collagen for Sinus Augmentation Using the Transcrestal Approach.
A study testing Geistlich Bio-Oss® Collagen and Geistlich Bio-Oss® Granules in people with Bone Loss and Missing Teeth, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
To assess vertical bone height gain with Geistlich Bio-Oss Collagen used in conjunction with simultaneous implant installation in transcrestal approach sinus augmentation. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Missing Teeth
- What is being tested?
- Geistlich Bio-Oss® Collagen and Geistlich Bio-Oss® Granules
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Oct 2020to 17 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients above the age of 18.
- Patients with edentulous ridge maximal height of 8mm≥ beneath the maxillary sinus.
- Patients with edentulous ridge minimal height of 3mm≤ beneath the maxillary sinus.
- Patients who need single implant placement at the posterior maxilla.
- Signed, well filled and dated informed consent form.
Who cannot join
- Inability to complete or understand the informed consent process.
- Pregnant women.
- Lactating women.
- Patients who use medications that affect bone metabolism such as IV bisphosphonates.
- Heavy smokers.
- Patients with chronic/acute sinus infections
Trial locations and contacts
1 site in 1 country.
About this study
To assess vertical bone height gain with Geistlich Bio-Oss Collagen used in conjunction with simultaneous implant installation in transcrestal approach sinus augmentation.
Read the detailed description
One of the most common situations in the posterior maxilla is reduced alveolar bone height as a result of tooth extraction and the following bone remodeling process, and maxillary sinus pneumatization. Lack of alveolar bone volume may compromise dental implant installation. Maxillary sinus augmentation is considered a very predictable solution for implant installation in limited amount of bone in the posterior maxilla. In general, there are two main maxillary sinus augmentation methods: the lateral approach and the transcrestal. In both methods, the idea is to expend the alveolar ridge in vertical direction on the expense of the maxillary sinus. Sinus augmentation using the transcrestal approach is a well known procedure which is being use for over 40 years. As time goes by, implant dentistry is evolving and improving, there is a constant progress in this field including new bone substitutes materials.
Geistlich Bio-Oss® Collagen - can improve the results obtained by sinus augmentation using the transcrestal approach, by better ease of use for the operator which makes it easier for the operator and the patient.
Study hypothesis: The vertical bone height gained by using Geistlich Bio-Oss Collagen in transcrestal approach sinus augmentation will be comparable to using Bio-Oss Collagen, with greater operator satisfaction and less intra-operative complications.
- Conditions
- Bone Loss, Missing Teeth
- Being tested
- Geistlich Bio-Oss® Collagen, Geistlich Bio-Oss® Granules
- Medical subject headings
- Bone Diseases, Metabolic, Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geistlich Bio-Oss® CollagenDevice
Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation.
Geistlich Bio-Oss® GranulesDevice
Geistlich Bio-Oss® Granules is intended to be used for filling bone defects and for bone augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Bio-Oss Collagen | Experimental | Transcrestal approach sinus augmentation using Geistlich Bio-Oss Collagen®. Receives: Device: Geistlich Bio-Oss® Collagen |
| Bio-Oss Granules | Active comparator | Transcrestal approach sinus augmentation using Geistlich Bio-Oss®. Receives: Device: Geistlich Bio-Oss® Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical bone height. (mm)Changes in augmented bone after transcrestal approach sinus augmentation.
Measuring the changes in augmented bone volume after transcrestal approach sinus augmentation.
Measured: Pre op; immediately post-op, at 6 months and 3 years from second stage surgery.
Secondary outcomes (4)
Procedure time measurement. (min)
To evaluate the time needed for transcrestal approach sinus augmentation using Bio-Oss collagen® and in the conventional way, using Bio-Oss granules.
Measured: The procedure time measurement will start after flaps are elevated at pilot drilling (2.4mm diameter). and it will be stopped when the implant was inserted and insertion torque was assessed.
Patients and operator satisfaction. (1-10 ruler scale)
To study operator and patients satisfaction using the 2 materials. They will be assessed by giving the patients questionnaires and satisfaction ruler using a 1-10 ruler scale.
Measured: At the suture removal visit - 14 days after procedure.
Complications
Explore intra and post operative complications.
Measured: During the procedure, During the follow up - 14 days, 6 months after intervention.
The success rate of osseointegrated implants. (%)
The percentage of osseointegrated implants that were installed with simultaneous transcrestal approach sinus augmentation.- using Bio-Oss collagen®.
Measured: At 6 months and 3.5 years after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start15 Oct 2020
- Primary completion17 Dec 2026 (estimated)
- Study completion17 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadar Zigdon MD, Rambam Health Care Campus
- Investigators
- Hadar Zigdon, DMD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581304
- Sponsor's protocol ID
- 0136-20-RMB CTIL
- Status last verified
- Nov 2025
- First submitted
- 4 Oct 2020
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Bio-Oss Collagen for Sinus Augmentation Using the Transcrestal Approach.
- ClinicalTrials.gov ID
- NCT04581304
- Acronym / sponsor ID
- 0136-20-RMB CTIL
- Conditions
- Bone Loss, Missing Teeth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 17 Jan 2028 (estimated)
- First posted
- 9 Oct 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.
To assess vertical bone height gain with Geistlich Bio-Oss Collagen used in conjunction with simultaneous implant installation in transcrestal approach sinus augmentation.
Detailed description
One of the most common situations in the posterior maxilla is reduced alveolar bone height as a result of tooth extraction and the following bone remodeling process, and maxillary sinus pneumatization. Lack of alveolar bone volume may compromise dental implant installation. Maxillary sinus augmentation is considered a very predictable solution for implant installation in limited amount of bone in the posterior maxilla. In general, there are two main maxillary sinus augmentation methods: the lateral approach and the transcrestal. In both methods, the idea is to expend the alveolar ridge in vertical direction on the expense of the maxillary sinus. Sinus augmentation using the transcrestal approach is a well known procedure which is being use for over 40 years. As time goes by, implant dentistry is evolving and improving, there is a constant progress in this field including new bone substitutes materials.
Geistlich Bio-Oss® Collagen - can improve the results obtained by sinus augmentation using the transcrestal approach, by better ease of use for the operator which makes it easier for the operator and the patient.
Study hypothesis: The vertical bone height gained by using Geistlich Bio-Oss Collagen in transcrestal approach sinus augmentation will be comparable to using Bio-Oss Collagen, with greater operator satisfaction and less intra-operative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-Oss Collagen | Experimental | Device: Geistlich Bio-Oss® CollagenTranscrestal approach sinus augmentation using Geistlich Bio-Oss Collagen®. |
| Bio-Oss Granules | Active comparator | Device: Geistlich Bio-Oss® GranulesTranscrestal approach sinus augmentation using Geistlich Bio-Oss®. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients above the age of 18.
- Patients with edentulous ridge maximal height of 8mm≥ beneath the maxillary sinus.
- Patients with edentulous ridge minimal height of 3mm≤ beneath the maxillary sinus.
- Patients who need single implant placement at the posterior maxilla.
- Signed, well filled and dated informed consent form.
Key exclusion criteria (6 listed)
- Inability to complete or understand the informed consent process.
- Pregnant women.
- Lactating women.
- Patients who use medications that affect bone metabolism such as IV bisphosphonates.
- Heavy smokers.
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 |
|---|---|---|
| Geistlich Bio-Oss® CollagenGeistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation. | Device | Bio-Oss Collagen |
| Geistlich Bio-Oss® GranulesGeistlich Bio-Oss® Granules is intended to be used for filling bone defects and for bone augmentation. | Device | Bio-Oss Granules |
Primary outcome
Vertical bone height. (mm)Changes in augmented bone after transcrestal approach sinus augmentation.
Time frame: Pre op; immediately post-op, at 6 months and 3 years from second stage surgery.
Measuring the changes in augmented bone volume after transcrestal approach sinus augmentation.
4 secondary outcomes
Procedure time measurement. (min)
Time frame: The procedure time measurement will start after flaps are elevated at pilot drilling (2.4mm diameter). and it will be stopped when the implant was inserted and insertion torque was assessed.
Patients and operator satisfaction. (1-10 ruler scale)
Time frame: At the suture removal visit - 14 days after procedure.
Complications
Time frame: During the procedure, During the follow up - 14 days, 6 months after intervention.
The success rate of osseointegrated implants. (%)
Time frame: At 6 months and 3.5 years after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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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.
Hadar Zigdon, DMD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geistlich Bio-Oss® Collagen and Geistlich Bio-Oss® Granules in people with Bone Loss and Missing Teeth, run by Rambam Health Care Campus at 1 site in Israel.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. 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 Israel. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Vertical bone height. (mm)Changes in augmented bone after transcrestal approach sinus augmentation. (time frame: Pre op; immediately post-op, at 6 months and 3 years from second stage surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.