The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures
Primary Purpose
Edentulism, Alveolar Bone Atrophy, Sinus Pneumatization
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sinus grafting using allogenic bone
Sponsored by
About this trial
This is an interventional treatment trial for Edentulism focused on measuring Implant site development, Bone grafting, Dental implants
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.
Sites / Locations
- Graduate Periodontics Clinic. School of Dentistry. University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sinus grafting using allogenic bone
Arm Description
Outcomes
Primary Outcome Measures
Histomorphometric proportion of vital bone
Secondary Outcome Measures
Full Information
NCT ID
NCT00868777
First Posted
March 24, 2009
Last Updated
September 24, 2009
Sponsor
University of Michigan
Collaborators
BioHorizons, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00868777
Brief Title
The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures
Official Title
The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Michigan
Collaborators
BioHorizons, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulism, Alveolar Bone Atrophy, Sinus Pneumatization
Keywords
Implant site development, Bone grafting, Dental implants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sinus grafting using allogenic bone
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Sinus grafting using allogenic bone
Other Intervention Name(s)
Mineross - Human allograft
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Graduate Periodontics Clinic. School of Dentistry. University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18573123
Citation
Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Mesa F, O'Valle-Ravassa F, Wang HL. Clinical and histologic comparison of two different composite grafts for sinus augmentation: a pilot clinical trial. Clin Oral Implants Res. 2008 Aug;19(8):755-9. doi: 10.1111/j.1600-0501.2008.01536.x.
Results Reference
background
PubMed Identifier
17355356
Citation
Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12.
Results Reference
background
PubMed Identifier
19248167
Citation
Gosau M, Rink D, Driemel O, Draenert FG. Maxillary sinus anatomy: a cadaveric study with clinical implications. Anat Rec (Hoboken). 2009 Mar;292(3):352-4. doi: 10.1002/ar.20859.
Results Reference
background
Links:
URL
http://www.biohorizons.com/mineross.aspx
Description
Allograft material used in the study
Learn more about this trial
The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures
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