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Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01942304
First Posted: September 13, 2013
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NovaBone Products, LLC
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
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.

Condition Intervention
Sinus Floor Augmentation Maxillary Sinus Procedure: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation Procedure: Anorganic bovine bone mineral in direct sinus augmentation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Gain in vertical bone height [ Time Frame: 6 months (plus or minus 1month) ]
    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.

  • Radiographic bone density [ Time Frame: 6 months (plus or minus 1 month) ]
    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.

  • Primary implant stability [ Time Frame: 7 months (plus or minus 1 month) ]
    Primary stability of implants placed in the augmented sinuses will be evaluated as a clinical index of bone density.

  • Marginal bone level maintenance [ Time Frame: 12 months(plus or minus 1 month) ]
    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.


Other Outcome Measures:
  • Implant success [ Time Frame: 2nd stage, 6&12 months post-loading ]
    Patients will be evaluated for clinical symptoms and implant success using predetermined criteria.


Estimated Enrollment: 12
Study Start Date: October 2013
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anorganic bovine bone mineral in direct sinus augmentation
Anorganic bovine bone mineral
Procedure: Anorganic bovine bone mineral in direct sinus augmentation
Experimental: Alloplastic bone putty in direct sinus augmentation
Alloplastic bone putty
Procedure: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with non-contributory medical history that will present for bilateral sinus lift surgery prior to implant placement

Exclusion Criteria:

  • 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.)
  • 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942304


Locations
United States, Minnesota
Advanced Education in Periodontology Clinic, Dental School, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
NovaBone Products, LLC
Investigators
Principal Investigator: Georgios A Kotsakis, DDS University of Minnesota - Clinical and Translational Science Institute
Study Director: James E Hinrichs, DDS, MS University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01942304     History of Changes
Other Study ID Numbers: 002
First Submitted: September 10, 2013
First Posted: September 13, 2013
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Sinus Floor Augmentation
Maxillary Sinus
Bone Substitutes
Bone Regeneration

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs