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Clinical Trials/NCT00868777
NCT00868777
Completed
Phase 4

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

University of Michigan1 site in 1 country25 target enrollmentJanuary 2008

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Edentulism
Sponsor
University of Michigan
Enrollment
25
Locations
1
Primary Endpoint
Histomorphometric proportion of vital bone
Status
Completed
Last Updated
16 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
March 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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