Sinus Floor AugmentationNCT01942304
Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study
A study testing Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation and Anorganic bovine bone mineral in direct sinus augmentation in people with Sinus Floor Augmentation and Maxillary Sinus, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS putty bone substitute in posterior maxillary sites and the survival of implants placed in these sites following healing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sinus Floor Augmentation, Maxillary Sinus
- What is being tested?
- Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation and Anorganic bovine bone mineral in direct sinus augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2013to 31 May 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with non-contributory medical history that will present for bilateral sinus lift surgery prior to implant placement
Who cannot join
- Patients that will not agree to participate in this study or sign the consent form
- More than 8mm of residual bone height at the implant site
- Subjects smoking more than 10 cigarettes per day
- History of acute sinus infection
- History of prior maxillary sinus surgery (Caldwell-Luc, direct or indirect sinus lift, etc)
- Medications that affect bone healing (chronic steroid regimen, oral or IV bisphosphonates, etc.)
Show all 9Show fewer
- Patients allergic to bovine derivatives
- Patients who are a carrier of transmissible disease(s) that may unnecessarily expose laboratory personnel to risks
- Females during pregnancy or lactation or females that plan to become pregnant in the following year (pregnancy test prior to enrollment)
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Education in Periodontology Clinic, Dental School, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS putty bone substitute in posterior maxillary sites and the survival of implants placed in these sites following healing.
- Conditions
- Sinus Floor Augmentation, Maxillary Sinus
- Being tested
- Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation, Anorganic bovine bone mineral in direct sinus augmentation
- Keywords
- Sinus Floor Augmentation, Maxillary Sinus, Bone Substitutes, Bone Regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium phosphosilicate alloplastic bone putty in direct sinus augmentationProcedure or surgery
Anorganic bovine bone mineral in direct sinus augmentationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Anorganic bovine bone mineral in direct sinus augmentation | Active comparator | Anorganic bovine bone mineral Receives: Procedure: Anorganic bovine bone mineral in direct sinus augmentation |
| Alloplastic bone putty in direct sinus augmentation | Experimental | Alloplastic bone putty Receives: Procedure: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of new bone growth in the maxillary sinus
Difference between the percentage of new bone growth between the two groups as determined by histomorphometric analysis of bone cores retrieved during implant placement surgery.
Measured: 7 months(plus minus 1 month)
Secondary outcomes (4)
Gain in vertical bone height
Patients will be seen for radiographic evaluation post-sinus surgery. A cone beam computed tomography (CBCT) will be obtained and a blinded investigator will evaluate the vertical bone height at the sites.
Measured: 6 months (plus or minus 1month)
Radiographic bone density
Patients will be seen for radiographic evaluation. A cone beam computed tomography(CBCT) will be obtained and a blinded investigator will evaluate the volumetric grey values at each site as an index of bone quality.
Measured: 6 months (plus or minus 1 month)
Primary implant stability
Primary stability of implants placed in the augmented sinuses will be evaluated as a clinical index of bone density.
Measured: 7 months (plus or minus 1 month)
Marginal bone level maintenance
Intraoral radiographs, using a paralleling technique, with customized film holders will be obtained at baseline (time of abutment connection) and at the 12-month follow-up visit and evaluated by an independent investigator to assess marginal bone levels around the implant platform. The measurements will be performed mesially and distally of each implant.
Measured: 12 months(plus or minus 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study start1 Oct 2013
- Primary completion1 Feb 2018
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sinus Floor AugmentationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- NovaBone Products, LLC
- Responsible party
- Sponsor
- Investigators
- Georgios A Kotsakis, DDS, Principal investigator, University of MinnesotaJames E Hinrichs, DDS, MS, Study director, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942304
- Sponsor's protocol ID
- 1308M40681
- Status last verified
- Oct 2019
- First submitted
- 10 Sep 2013
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hallman M, Sennerby L, Lundgren S. A clinical and histologic evaluation of implant integration in the posterior maxilla after sinus floor augmentation with autogenous bone, bovine hydroxyapatite, or a 20:80 mixture. Int J Oral Maxillofac Implants. 2002 Sep-Oct;17(5):635-43.
PubMed 12381063Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.
PubMed 15626319Mahesh L, Venkataraman N, Shukla S, Prasad H, Kotsakis GA. Alveolar ridge preservation with the socket-plug technique utilizing an alloplastic putty bone substitute or a particulate xenograft: a histological pilot study. J Oral Implantol. 2015 Apr;41(2):178-83. doi: 10.1563/AAID-JOI-D-13-00025. Epub 2013 Jun 17.
PubMed 23772806
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study
- ClinicalTrials.gov ID
- NCT01942304
- Acronym / sponsor ID
- 1308M40681
- Conditions
- Sinus Floor Augmentation, Maxillary Sinus
- Keywords
- Sinus Floor Augmentation, Maxillary Sinus, Bone Substitutes, Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- NovaBone Products, LLC
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 13 Sep 2013 (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 purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS putty bone substitute in posterior maxillary sites and the survival of implants placed in these sites following healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorganic bovine bone mineral in direct sinus augmentation | Active comparator | Procedure: Anorganic bovine bone mineral in direct sinus augmentationAnorganic bovine bone mineral |
| Alloplastic bone putty in direct sinus augmentation | Experimental | Procedure: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentationAlloplastic bone putty |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with non-contributory medical history that will present for bilateral sinus lift surgery prior to implant placement
Key exclusion criteria (9 listed)
- Patients that will not agree to participate in this study or sign the consent form
- More than 8mm of residual bone height at the implant site
- Subjects smoking more than 10 cigarettes per day
- History of acute sinus infection
- History of prior maxillary sinus surgery (Caldwell-Luc, direct or indirect sinus lift, etc)
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 |
|---|---|---|
| Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation | Procedure or surgery | Alloplastic bone putty in direct sinus augmentation |
| Anorganic bovine bone mineral in direct sinus augmentation | Procedure or surgery | Anorganic bovine bone mineral in direct sinus augmentation |
Primary outcome
Percentage of new bone growth in the maxillary sinus
Time frame: 7 months(plus minus 1 month)
Difference between the percentage of new bone growth between the two groups as determined by histomorphometric analysis of bone cores retrieved during implant placement surgery.
4 secondary outcomes
Gain in vertical bone height
Time frame: 6 months (plus or minus 1month)
Radiographic bone density
Time frame: 6 months (plus or minus 1 month)
Primary implant stability
Time frame: 7 months (plus or minus 1 month)
Marginal bone level maintenance
Time frame: 12 months(plus or minus 1 month)
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 Nov 2019.
- Background: PubMed 12381063Hallman M, Sennerby L, Lundgren S. A clinical and histologic evaluation of implant integration in the posterior maxilla after sinus floor augmentation with autogenous bone, bovine hydroxyapatite, or a 20:80 mixture. Int J Oral Maxillofac Implants. 2002 Sep-Oct;17(5):635-43.
- Background: PubMed 15626319Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.
- Background: PubMed 23772806Mahesh L, Venkataraman N, Shukla S, Prasad H, Kotsakis GA. Alveolar ridge preservation with the socket-plug technique utilizing an alloplastic putty bone substitute or a particulate xenograft: a histological pilot study. J Oral Implantol. 2015 Apr;41(2):178-83. doi: 10.1563/AAID-JOI-D-13-00025. Epub 2013 Jun 17.
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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.
Georgios A Kotsakis, DDS principal investigator
University of Minnesota
James E Hinrichs, DDS, MS study director
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation and Anorganic bovine bone mineral in direct sinus augmentation in people with Sinus Floor Augmentation and Maxillary Sinus, run by University of Minnesota at 1 site in United States.
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 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 1 Nov 2019. 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 United States. 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?
Percentage of new bone growth in the maxillary sinus (time frame: 7 months(plus minus 1 month)). 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 NCT01942304, which also lists 3 linked publications.
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 Nov 2019.