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

University of Minnesota1 site in 1 country12 target enrollmentOctober 1, 2013

ConditionsSinus Floor Augmentation Maxillary Sinus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sinus Floor Augmentation
Sponsor: University of Minnesota
Enrollment: 12
Locations: 1
Primary Endpoint: Percentage of new bone growth in the maxillary sinus
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 1, 2013

End Date

May 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Minnesota

Responsible Party

Sponsor

Eligibility 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)

Outcomes

Primary Outcomes

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.