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

Sinus Floor Augmentation research study

What is the primary objective of 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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sinus Floor Augmentation

Maxillary Sinus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation

Procedure:Anorganic bovine bone mineral in direct sinus augmentation

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Anorganic bovine bone mineral in direct sinus augmentationAnorganic bovine bone mineral

Alloplastic bone putty in direct sinus augmentationAlloplastic bone putty

Study Status

Completed

Start Date: October 1, 2013

Completed Date: May 31, 2019

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Percentage of new bone growth in the maxillary sinus

Secondary Outcome: Gain in vertical bone height

Study sponsors, principal investigator, and references

Principal Investigator: Georgios A Kotsakis, DDS

Lead Sponsor: University of Minnesota - Clinical and Translational Science Institute

Collaborator: NovaBone Products, LLC

More information:https://clinicaltrials.gov/show/NCT01942304

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.

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