Clinical trial NCT01942304: Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study
Official title: Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Floor Augmentation
Maxillary Sinus
Keywords: Sinus Floor Augmentation
Maxillary Sinus
Bone Substitutes
Bone Regeneration
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: NovaBone Products, LLC
First posted: 2013-09-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Percentage of new bone growth in the maxillary sinus
timeFrame: 7 months(plus minus 1 month)
Secondary outcomes:
measure: Gain in vertical bone height
timeFrame: 6 months (plus or minus 1month)
measure: Radiographic bone density
timeFrame: 6 months (plus or minus 1 month)
measure: Primary implant stability
timeFrame: 7 months (plus or minus 1 month)
measure: Marginal bone level maintenance
timeFrame: 12 months(plus or minus 1 month)
Other outcomes:
measure: Implant success
timeFrame: 2nd stage, 6&12 months post-loading
Locations:
city: Minneapolis
country: United States
facility: Advanced Education in Periodontology Clinic, Dental School, University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Georgios A Kotsakis, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: James E Hinrichs, DDS, MS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.
citation: Mahesh L, Venkataraman N, Shukla S, Prasad H, Kotsakis GA. Alveolar ridge preservation with the socket-plug technique utilizing an alloplastic putty bone substitute or a particulate xenograft: a histological pilot study. J Oral Implantol. 2015 Apr;41(2):178-83. doi: 10.1563/AAID-JOI-D-13-00025. Epub 2013 Jun 17.