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

September 24, 2009 updated by: University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Graduate Periodontics Clinic. School of Dentistry. University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sinus grafting using allogenic bone
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.
Other Names:
  • Mineross - Human allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Six months after sinus bone grafting, after harvesting a bone core biopsy at the time of implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

BioHorizons, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

March 24, 2009

First Submitted That Met QC Criteria

March 24, 2009

First Posted (ESTIMATE)

March 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 25, 2009

Last Update Submitted That Met QC Criteria

September 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00017520

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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