The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00868777
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : September 25, 2009
BioHorizons, Inc.
Information provided by:
University of Michigan

Brief Summary:
The hypothesis of this study is that there is a significant difference in bone maturation after sinus grafting determined by the distance from the buccal to the palatal wall of this cavity.

Condition or disease Intervention/treatment Phase
Edentulism Alveolar Bone Atrophy Sinus Pneumatization Procedure: Sinus grafting using allogenic bone Phase 4

Detailed Description:

Inadequate alveolar bone height as a consequence of tooth loss is a common limitation for properly placing endosseous dental implants in the posterior maxilla. Grafting of the maxillary sinus has been regarded as one of the most reliable surgical alternatives to correct this problem. Several sinus grafting techniques, using different materials, have been reported showing high survival rates. However, there are many factors that may alter the outcomes of this procedure.

The maturation and consolidation of the grafted area relies on the proper formation of a functional graft-vital bone complex. This maturation process requires an adequate migration of osteogenic cells from native bone, that could be limited in situations where the dimensions of the maxillary sinus are excessive. Hence, the purpose of this research project is to determine the influence of the distance from the lateral to the medial wall of the maxillary sinus on the outcomes of a sinus augmentation procedures performed using the lateral approach using clinical, radiographic and histomorphometric analysis.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures
Study Start Date : January 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: Sinus grafting using allogenic bone Procedure: Sinus grafting using allogenic bone
Surgical bone grafting procedure oriented to provide enough bone volume in atrophic posterior maxillary segments, when placement of endosteal implants is planned in order to restore missing teeth.
Other Name: Mineross - Human allograft

Primary Outcome Measures :
  1. Histomorphometric proportion of vital bone [ Time Frame: Six months after sinus bone grafting, after harvesting a bone core biopsy at the time of implant placement ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults patients (Older than 18 years), up to 85 years-old.
  • Physical status according to the American Society of Anesthesiologists (ASA) I or II
  • Patient in need of a sinus grafting using the lateral approach to allow the proper placement of dental implants. The remaining bone height must be 3 mm or less.
  • No uncontrolled systemic disease or condition known to alter bone metabolism
  • Adequate oral hygiene (O'Leary plaque score ≤20%)

Exclusion Criteria:

  • Long term (>2 weeks) use of antibiotics in the past 3 months
  • Patients smoking more than half-pack a day
  • Patients taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, etc…)
  • Pregnant or attempting to get pregnant
  • Patients that don't meet the indications for sinus grafting (Existing sinus conditions, sepsis, history of cancer and/or radiation to the oral cavity, use of biphosphonates, pregnancy), or have postoperative complications related to those conditions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00868777

United States, Michigan
Graduate Periodontics Clinic. School of Dentistry. University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
BioHorizons, Inc.

Additional Information:
Responsible Party: Gustavo Avila-Ortiz, University of Michigan Identifier: NCT00868777     History of Changes
Other Study ID Numbers: HUM00017520
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: September 25, 2009
Last Verified: March 2009

Keywords provided by University of Michigan:
Implant site development
Bone grafting
Dental implants

Additional relevant MeSH terms:
Alveolar Bone Loss
Pathological Conditions, Anatomical
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases