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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Edentulism Alveolar Bone Atrophy Sinus Pneumatization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sinus grafting using allogenic bone

Group Type EXPERIMENTAL

Sinus grafting using allogenic bone

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Mineross - Human allograft

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No