Clinical trial NCT00868777: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Edentulism
Alveolar Bone Atrophy
Sinus Pneumatization
Keywords: Implant site development
Bone grafting
Dental implants
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: BioHorizons, Inc.
First posted: 2009-03-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Histomorphometric proportion of vital bone
timeFrame: Six months after sinus bone grafting, after harvesting a bone core biopsy at the time of implant placement
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Graduate Periodontics Clinic. School of Dentistry. University of Michigan
state: Michigan
Study officials:
References:
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.
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.
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.