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

Phase 4

Completed

• Conditions: Edentulism; Alveolar Bone Atrophy; Sinus Pneumatization
• Interventions: Procedure: Sinus grafting using allogenic bone

• Registration Number: NCT00868777
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2009-02
• Status Verified: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Last Update Submitted: 2009-09-24
• Last Update Posted: 2009-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sinus grafting using allogenic bone	Sinus grafting using allogenic bone	-

Primary Outcome Measures

Name	Time	Method
Histomorphometric proportion of vital bone	Six months after sinus bone grafting, after harvesting a bone core biopsy at the time of implant placement

Trial Locations

Locations (1)

Graduate Periodontics Clinic. School of Dentistry. University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States