Sinus GraftNCT00426322
Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral.
A study testing bovine bone mineral particles (Bio-Oss®) in people with Sinus Graft, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The aim of this clinical study is to compare the amount of newly formed bone after bone augmentation with Bio-Oss® (BO) 0.25-1 mm vs. Bio-Oss® (BO) 1-2 mm in the sinus floor augmentation procedure bilaterally in 8 patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinus Graft
- What is being tested?
- bovine bone mineral particles (Bio-Oss®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2007to Dec 2008
- 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
- The patients included in this study are over 18 year old men and women.
- The patient must be a candidate for sinus floor augmentation.
- The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures.
- The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.
Who cannot join
- Pregnant women.
- People who smoke more than 10 cigarettes a day.
- Alcohol and drug abusers.
- People suffering from uncontrolled diabetes, severe osteoporosis, rheumatic arthritis, precancer or neoplastic lesions of oral cavity.
- The patient is nursing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Sinus Floor Augmentation Using Large (1-2mm) or Small (0.25-1mm) Bovine Bone Mineral Particles (Bio-Oss®): A Comparative Histomorphometric Clinical Study
The aim of this clinical study is to compare the amount of newly formed bone after bone augmentation with Bio-Oss® (BO) 0.25-1 mm vs. Bio-Oss® (BO) 1-2 mm in the sinus floor augmentation procedure bilaterally in 8 patients.
Hypothesis:
There is no difference in the relative amount of newly formed bone plus BO between the large (1-2 mm) and small (0.25 - 1 mm) granules.
Read the detailed description
the use of bovine bone mineral particles (Bio-Oss®)in sinus floor augmentation is well established. bovine bone mineral is an oseoconductive material which serves as a space maintainer and a scaffold for bone augmentation. the commercial product is manufactured in two different particles sizes, "large"1-2 mm, and "small"0.25-1 mm.
Comparison: the histologic characteristics of augmented bone after the use of Bio-Oss® (BO) with particle size of 0.25-1 mm vs. Bio-Oss® (BO)with particle size of 1-2 mm.
- Conditions
- Sinus Graft
- Being tested
- bovine bone mineral particles (Bio-Oss®)
- Keywords
- maxillary sinus augmentation, bone graft, bovine bone mineral, dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bovine bone mineral particles (Bio-Oss®)Device
Also called bovine bone mineral particles (Bio-Oss®) small particles, bovine bone mineral particles (Bio-Oss®) large particles
bovine bone mineral particles used for sinus augmentation prior to dental implant placement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | small particles Receives: Device: bovine bone mineral particles (Bio-Oss®) |
| 2 | Active comparator | large particles Receives: Device: bovine bone mineral particles (Bio-Oss®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the relative amount of mineralised tissue (=newly formed bone plus BO)
Measured: 20 monthes
Secondary outcomes (6)
Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue.
Measured: 20 monthes
Clinical parameters:
Measured: 32 monthes
complications during surgery related to the material.
Measured: 20 monthes
post-operative complications.
Measured: 20 monthes
Max torque for implant insertion.
Measured: 20 monthes
short-term implant survival (up to one year post loading)
Measured: 32 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus GraftStudies 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
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lior Shapira, Hadassah Medical Organization
- Investigators
- Lior Shapira, PhD, DMD, Principal investigator, department of periodontology, Hadassah Medical OrganizationTali Chackartchi, DMD, Study director, department of periodontology,Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426322
- Sponsor's protocol ID
- shapiral-HMO-CTIL
- Status last verified
- Sep 2013
- First submitted
- 23 Jan 2007
- Last updated
- 10 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sinus Floor Augmentation Using Large (1-2mm) or Small (0.25-1mm) Bovine Bone Mineral Particles (Bio-Oss®): A Comparative Histomorphometric Clinical Study
- ClinicalTrials.gov ID
- NCT00426322
- Acronym / sponsor ID
- shapiral-HMO-CTIL
- Conditions
- Sinus Graft
- Keywords
- maxillary sinus augmentation, bone graft, bovine bone mineral, dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Jan 2007 (estimated)
- 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.
The aim of this clinical study is to compare the amount of newly formed bone after bone augmentation with Bio-Oss® (BO) 0.25-1 mm vs. Bio-Oss® (BO) 1-2 mm in the sinus floor augmentation procedure bilaterally in 8 patients.
Hypothesis:
There is no difference in the relative amount of newly formed bone plus BO between the large (1-2 mm) and small (0.25 - 1 mm) granules.
Detailed description
the use of bovine bone mineral particles (Bio-Oss®)in sinus floor augmentation is well established. bovine bone mineral is an oseoconductive material which serves as a space maintainer and a scaffold for bone augmentation. the commercial product is manufactured in two different particles sizes, "large"1-2 mm, and "small"0.25-1 mm.
Comparison: the histologic characteristics of augmented bone after the use of Bio-Oss® (BO) with particle size of 0.25-1 mm vs. Bio-Oss® (BO)with particle size of 1-2 mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: bovine bone mineral particles (Bio-Oss®)small particles |
| 2 | Active comparator | Device: bovine bone mineral particles (Bio-Oss®)large particles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients included in this study are over 18 year old men and women.
- The patient must be a candidate for sinus floor augmentation.
- The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures.
- The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.
Key exclusion criteria (5 listed)
- Pregnant women.
- People who smoke more than 10 cigarettes a day.
- Alcohol and drug abusers.
- People suffering from uncontrolled diabetes, severe osteoporosis, rheumatic arthritis, precancer or neoplastic lesions of oral cavity.
- The patient is nursing.
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 |
|---|---|---|
| bovine bone mineral particles (Bio-Oss®)Also: bovine bone mineral particles (Bio-Oss®) small particles, bovine bone mineral particles (Bio-Oss®) large particlesbovine bone mineral particles used for sinus augmentation prior to dental implant placement | Device | 1, 2 |
Primary outcome
the relative amount of mineralised tissue (=newly formed bone plus BO)
Time frame: 20 monthes
6 secondary outcomes
Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue.
Time frame: 20 monthes
Clinical parameters:
Time frame: 32 monthes
complications during surgery related to the material.
Time frame: 20 monthes
post-operative complications.
Time frame: 20 monthes
Max torque for implant insertion.
Time frame: 20 monthes
short-term implant survival (up to one year post loading)
Time frame: 32 monthes
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 10 Sep 2013.
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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.
Lior Shapira, PhD, DMD principal investigator
department of periodontology, Hadassah Medical Organization
Tali Chackartchi, DMD study director
department of periodontology,Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bovine bone mineral particles (Bio-Oss®) in people with Sinus Graft, run by Hadassah Medical Organization 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 4 inclusion and 5 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 10 Sep 2013. 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?
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?
the relative amount of mineralised tissue (=newly formed bone plus BO) (time frame: 20 monthes). 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 10 Sep 2013.