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

This study is currently recruiting participants.
Verified October 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
NovaBone Products, LLC
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01942304
First received: September 10, 2013
Last updated: October 21, 2013
Last verified: October 2013
  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 Blind (Subject, 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2015
Estimated Primary Completion Date: March 2015 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01942304

Contacts
Contact: Georgios A Kotsakis, DDS 6513959200 kotsa001@umn.edu

Locations
United States, Minnesota
Advanced Education in Periodontology Clinic, Dental School, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Georgios A Kotsakis, DDS       kotsa001@umn.edu   
Principal Investigator: Georgios A Kotsakis, DDS         
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
Study First Received: September 10, 2013
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014