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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00868777
Enrollment
25
Registered
2009-03-25
Start date
2008-01-31
Completion date
2009-03-31
Last updated
2009-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Atrophy, Edentulism, Sinus Pneumatization

Keywords

Implant site development, Bone grafting, Dental implants

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.

Interventions

PROCEDURESinus 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.

Sponsors

BioHorizons, Inc.
CollaboratorINDUSTRY
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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.

Design outcomes

Primary

MeasureTime frame
Histomorphometric proportion of vital boneSix months after sinus bone grafting, after harvesting a bone core biopsy at the time of implant placement

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026