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

Not Applicable

Completed

• Conditions: Sinus Floor Augmentation; Maxillary Sinus

• Registration Number: NCT01942304
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-13
• Study Start: 2013-10-01
• Primary Completion: 2018-02-01
• Study Completion: 2019-05-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of new bone growth in the maxillary sinus	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.

Secondary Outcome Measures

Name	Time	Method
Gain in vertical bone height	6 months (plus or minus 1month)	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.
Primary implant stability	7 months (plus or minus 1 month)	Primary stability of implants placed in the augmented sinuses will be evaluated as a clinical index of bone density.
Radiographic bone density	6 months (plus or minus 1 month)	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.
Marginal bone level maintenance	12 months(plus or minus 1 month)	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.

Trial Locations

Locations (1)

Advanced Education in Periodontology Clinic, Dental School, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States