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

University of Minnesota (UMN)

Status

Completed

Conditions

Sinus Floor Augmentation

Maxillary Sinus

Treatments

Procedure: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation

Procedure: Anorganic bovine bone mineral in direct sinus augmentation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01942304

1308M40681

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)