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

Alveolar Bone Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868777
• Other study ID #: HUM00017520
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2009
• Last updated: September 24, 2009
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Bone Atrophy
• Alveolar Bone Loss
• Edentulism
• Sinus Pneumatization

Intervention

Procedure:
• Sinus 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.

Locations

Country	Name	City	State
United States	Graduate Periodontics Clinic. School of Dentistry. University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	BioHorizons, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Galindo-Moreno P, Avila G, Fernández-Barbero JE, Aguilar M, Sánchez-Fernández 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. Epub 2007 Mar 12. — View Citation

Galindo-Moreno P, Avila G, Fernández-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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histomorphometric proportion of vital bone		Six months after sinus bone grafting, after harvesting a bone core biopsy at the time of implant placement	No

External Links

•   Allograft material used in the study