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

This study has been completed.
Sponsor:
Collaborator:
BioHorizons, Inc.
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00868777
First received: March 24, 2009
Last updated: September 24, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Edentulism
Alveolar Bone Atrophy
Sinus Pneumatization
 Procedure: Sinus grafting using allogenic bone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868777

Locations
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.
  More Information

Additional Information:
UM Graduate Periodontics website  This link exits the ClinicalTrials.gov site
Allograft material used in the study  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Gustavo Avila-Ortiz, University of Michigan
ClinicalTrials.gov Identifier: NCT00868777     History of Changes
Other Study ID Numbers: HUM00017520
Study First Received: March 24, 2009
Last Updated: September 24, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013