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

Maxillary Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942304
• Other study ID #: 1308M40681
• Status: Completed
• Phase: N/A
• Start date: October 1, 2013
• Est. completion date: May 31, 2019

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 31, 2019
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Maxillary Sinus
• Sinus Floor Augmentation

Intervention

Procedure:
• Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation

• Anorganic bovine bone mineral in direct sinus augmentation

Locations

Country	Name	City	State
United States	Advanced Education in Periodontology Clinic, Dental School, University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	NovaBone Products, LLC

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implant success	Patients will be evaluated for clinical symptoms and implant success using predetermined criteria.	2nd stage, 6&12 months post-loading
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)