Maxillary SinusNCT03419338
Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone
A study testing Sinus lift, Surgical alveolus and Inorganic bovine bone + newly forming bone in people with Maxillary Sinus, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. For that, it will be compared the tomographic bone gain 6 months after surgery between a group that received inorganic bovine bone alone (n=8) and a group that received inorganic… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus
- What is being tested?
- Sinus lift, Surgical alveolus and Inorganic bovine bone + newly forming bone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2010to 30 Jun 2013
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presenting a distance between alveolar crest and maxillary sinus of 2 to 9 millimeters.
Who cannot join
- History of periodontal surgery at the area on the last 12 months
- Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based, contraceptives, steroids)
- Pregnant
- Smokers
- Diabetics
- History of head and neck radiotherapy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Bauru School of Dentistry - University of Sao Paulo
Bauru, São Paulo, 17012-901
About this study
Official title: Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone: a Clinical, Histologic and Histomorphometric Evaluation
The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. For that, it will be compared the tomographic bone gain 6 months after surgery between a group that received inorganic bovine bone alone (n=8) and a group that received inorganic bovine bone associated with NFB (n=8).
Read the detailed description
The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. It will be recruited for this study individuals 25-60 years of age, both genders, presenting a missing tooth at an upper premolar or molar region with 2-9 mm of remaining bone between alveolar ridge crest and sinus floor and the existence of an edentulous ridge or at least one tooth condemned to extraction. Sinus will be treated by NFB mixed to inorganic bovine bone - IBB (test; n= 8) or IBB (control; n= 8). The volume of bone tissue will be evaluated by computerized tomography obtained at baseline examination and 6 months after surgery. After this period, biopsies of hard tissue will be obtained during implant placement for histologic and histomorphometric analysis.
- Conditions
- Maxillary Sinus
- Being tested
- Sinus lift, Surgical alveolus, Inorganic bovine bone + newly forming bone, Inorganic bovine bone, Collagen membrane
- Keywords
- Maxillary Sinus, Sinus lifting, Bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus liftProcedure or surgery
Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material.
Surgical alveolusProcedure or surgery
Using a round diamond bur, a surgical alveolus will be created on an toothless ridge region.
Inorganic bovine bone + newly forming boneProcedure or surgery
Maxillary sinus lift will be done with inorganic bovine bone associated with newly forming bone. The newly forming bone will be collected from surgical alveolus previous prepared.
Inorganic bovine boneProcedure or surgery
Maxillary sinus lift will be done with inorganic bovine bone.
Collagen membraneDevice
At the end of the sinus lift, a collagen membrane will be used to obliterate the graft inside the maxillary sinus.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Surgical alveolus + maxillary sinus lift with inorganic bovine bone + newly forming bone + collagen membrane Receives: Procedure: Sinus lift; Procedure: Surgical alveolus; Procedure: Inorganic bovine bone + newly forming bone; Device: Collagen membrane |
| Control group | Active comparator | Maxillary sinus lift with inorganic bovine bone + collagen membrane Receives: Procedure: Sinus lift; Procedure: Inorganic bovine bone; Device: Collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone height measured in millimeters using the panoramic radiography reconstructions
It will be measured the distance between the alveolar ridge and the maxillary sinus in panoramic radiography reconstructions taken before and after sinus lift.
Measured: Six months
Secondary outcomes (3)
Descriptive histologic analysis of biopsy samples performed by two trained and previously calibrated examiners
On the surface and around the particles of the materials with the newformed reactive tissue, it was analyzed the presence and absence of the following tissue and reactive cellular elements: granulation tissue, newly formed blood vessels, fibroblasts, osteoblasts and mineralized bone matrix, foreign body type granuloma, macrophages, inflammatory multinucleated giant cells.
Measured: Six months
Quantitative histologic analysis of biopsy samples using Leahy et al. (2013) score
Quantification of the reactional and reparative phenomena related to cellular and tissue organization on biopsed samples were made using Leahy et al. (2013) score.
Measured: Six months
Histomorfometric analysis of biopsy samples using percentage of different tissues evaluated at ImageJ
The tissue sections were captured with 4x and 10x objective and images were recorded and later analyzed in the ImageJ software. The proportions of vital bone, cortical bone, medullary bone, remnant non-vital particles and connective tissue were quantified separately and expressed as percentages.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Mar 2010
- Primary completion1 Jun 2013
- Study completion30 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary SinusStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Campos Passanezi SantAna, University of Sao Paulo
- Investigators
- Adriana CP Sant'Ana, PhD, Principal investigator, Bauru School of Dentistry - University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419338
- Sponsor's protocol ID
- FOBGranSinus
- Status last verified
- Jan 2018
- First submitted
- 19 Oct 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone: a Clinical, Histologic and Histomorphometric Evaluation
- ClinicalTrials.gov ID
- NCT03419338
- Acronym / sponsor ID
- FOBGranSinus
- Conditions
- Maxillary Sinus
- Keywords
- Maxillary Sinus, Sinus lifting, Bone graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Mar 2010 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 1 Feb 2018 (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.
The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. For that, it will be compared the tomographic bone gain 6 months after surgery between a group that received inorganic bovine bone alone (n=8) and a group that received inorganic bovine bone associated with NFB (n=8).
Detailed description
The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. It will be recruited for this study individuals 25-60 years of age, both genders, presenting a missing tooth at an upper premolar or molar region with 2-9 mm of remaining bone between alveolar ridge crest and sinus floor and the existence of an edentulous ridge or at least one tooth condemned to extraction. Sinus will be treated by NFB mixed to inorganic bovine bone - IBB (test; n= 8) or IBB (control; n= 8). The volume of bone tissue will be evaluated by computerized tomography obtained at baseline examination and 6 months after surgery. After this period, biopsies of hard tissue will be obtained during implant placement for histologic and histomorphometric analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Sinus lift, Procedure: Surgical alveolus, Procedure: Inorganic bovine bone + newly forming bone, Device: Collagen membraneSurgical alveolus + maxillary sinus lift with inorganic bovine bone + newly forming bone + collagen membrane |
| Control group | Active comparator | Procedure: Sinus lift, Procedure: Inorganic bovine bone, Device: Collagen membraneMaxillary sinus lift with inorganic bovine bone + collagen membrane |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Presenting a distance between alveolar crest and maxillary sinus of 2 to 9 millimeters.
Key exclusion criteria (6 listed)
- History of periodontal surgery at the area on the last 12 months
- Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based, contraceptives, steroids)
- Pregnant
- Smokers
- Diabetics
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 liftUsing a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material. | Procedure or surgery | Control group, Test group |
| Surgical alveolusUsing a round diamond bur, a surgical alveolus will be created on an toothless ridge region. | Procedure or surgery | Test group |
| Inorganic bovine bone + newly forming boneMaxillary sinus lift will be done with inorganic bovine bone associated with newly forming bone. The newly forming bone will be collected from surgical alveolus previous prepared. | Procedure or surgery | Test group |
| Inorganic bovine boneMaxillary sinus lift will be done with inorganic bovine bone. | Procedure or surgery | Control group |
| Collagen membraneAt the end of the sinus lift, a collagen membrane will be used to obliterate the graft inside the maxillary sinus. | Device | Control group, Test group |
Primary outcome
Bone height measured in millimeters using the panoramic radiography reconstructions
Time frame: Six months
It will be measured the distance between the alveolar ridge and the maxillary sinus in panoramic radiography reconstructions taken before and after sinus lift.
3 secondary outcomes
Descriptive histologic analysis of biopsy samples performed by two trained and previously calibrated examiners
Time frame: Six months
Quantitative histologic analysis of biopsy samples using Leahy et al. (2013) score
Time frame: Six months
Histomorfometric analysis of biopsy samples using percentage of different tissues evaluated at ImageJ
Time frame: Six months
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 1 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Adriana CP Sant'Ana, PhD principal investigator
Bauru School of Dentistry - University of Sao Paulo
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 lift, Surgical alveolus and Inorganic bovine bone + newly forming bone in people with Maxillary Sinus, run by University of Sao Paulo at 1 site in Brazil.
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 1 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: finished, as of the sponsor's last update on 1 Feb 2018. 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 Brazil. 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?
Bone height measured in millimeters using the panoramic radiography reconstructions (time frame: Six months). 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 1 Feb 2018.