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

N/ACompletedNCT01942304

University of Minnesota12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sinus Floor Augmentation Maxillary Sinus

Interventions

Calcium phosphosilicate alloplastic bone putty in direct sinus augmentationPROCEDURE

Anorganic bovine bone mineral in direct sinus augmentationPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Advanced Education in Periodontology Clinic, Dental School, University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 7 months(plus minus 1 month)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months(plus or minus 1 month)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.