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

Study Overview

• Status: Completed
• Conditions: Sinus Floor Augmentation; Maxillary Sinus
• Intervention / Treatment: Procedure: Anorganic bovine bone mineral in direct sinus augmentation; Procedure: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Advanced Education in Periodontology Clinic, Dental School, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anorganic bovine bone mineral in direct sinus augmentation; Anorganic bovine bone mineral	Procedure: Anorganic bovine bone mineral in direct sinus augmentation
Experimental: Alloplastic bone putty in direct sinus augmentation; Alloplastic bone putty	Procedure: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of new bone growth in the maxillary sinus	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.	7 months(plus minus 1 month)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant success	Patients will be evaluated for clinical symptoms and implant success using predetermined criteria.	2nd stage, 6&12 months post-loading

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: NovaBone Products, LLC
• Investigators: Principal Investigator: Georgios A Kotsakis, DDS, University of Minnesota; Study Director: James E Hinrichs, DDS, MS, University of Minnesota

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Maxillary Sinus; Sinus Floor Augmentation; Bone Substitutes; Bone Regeneration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 1308M40681