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OpenTrials
Completed

NCT Number: NCT00868777

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Graduate Periodontics Clinic. School of Dentistry. University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sinus grafting using allogenic bone

Procedure

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.

Other names: Mineross - Human allograft

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • BioHorizons, Inc.

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 25, 2009
Registry last updated
Sep 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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