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Completed

NCT Number: NCT01942304

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.

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Key information

Conditions

Sinus Floor Augmentation Maxillary Sinus

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation

Procedure

Anorganic bovine bone mineral in direct sinus augmentation

Procedure

Primary outcomes

  1. Percentage of new bone growth in the maxillary sinus

    Time frame: 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 outcomes

  1. Gain in vertical bone height

    Time frame: 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.

  2. Radiographic bone density

    Time frame: 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.

  3. Primary implant stability

    Time frame: 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.

  4. Marginal bone level maintenance

    Time frame: 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.

Other outcomes

  1. Implant success

    Time frame: 2nd stage, 6&12 months post-loading

    Patients will be evaluated for clinical symptoms and implant success using predetermined criteria.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • NovaBone Products, LLC

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Sep 13, 2013
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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