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

March 24, 2009
September 24, 2009
January 2008
February 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00868777 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures
The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Edentulism
  • Alveolar Bone Atrophy
  • Sinus Pneumatization
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
Experimental: Sinus grafting using allogenic bone
Intervention: Procedure: Sinus grafting using allogenic bone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00868777
HUM00017520
No
Gustavo Avila-Ortiz, University of Michigan
University of Michigan
BioHorizons, Inc.
Not Provided
University of Michigan
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP