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Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later

NCT ID: NCT00711425

Last Updated: 2013-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Brief Summary

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The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior mandible in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.

Detailed Description

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Conditions

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Jaw, Edentulous, Partially

Keywords

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Jaw, Edentulous, Partially (posterior mandible)

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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A

Group Type EXPERIMENTAL

OsseoSpeed™

Intervention Type DEVICE

OsseoSpeed™, all dimensions

Interventions

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OsseoSpeed™

OsseoSpeed™, all dimensions

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Provision of written informed consent
* 18 years of age and over
* Edentulous in the posterior mandible, Kennedy class I or class II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
* Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading

Exclusion Criteria

* Untreated caries and/or periodontal disease of residual dentition
* History of edentulism in the area of implant placement of less than two months
* Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
* History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
* Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Present alcohol or drug abuse
* Unable or unwilling to return for follow-up visits for a period of 5 years
* Current use of smoking tobacco
* Pregnancy or lactation at the time of enrollment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edwin A McGlumphy, D.D.S.

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University, College of Dentistry

Locations

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The Ohio State University, College of Dentistry

Columbus, Ohio, United States

Site Status

University of Washington, Dept. of Restorative Dentistry

Seattle, Washington, United States

Site Status

Georg-August-Universität, Göttingen, Abt. Mund-, Keifer-, und Gesicthschirurgie

Göttingen, , Germany

Site Status

Countries

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United States Germany

References

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Schliephake H, Rodiger M, Phillips K, McGlumphy EA, Chacon GE, Larsen P. Early loading of surface modified implants in the posterior mandible - 5 year results of an open prospective non-controlled study. J Clin Periodontol. 2012 Feb;39(2):188-95. doi: 10.1111/j.1600-051X.2011.01816.x. Epub 2011 Nov 23.

Reference Type RESULT
PMID: 22111584 (View on PubMed)

Other Identifiers

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YA-OSS-0002

Identifier Type: -

Identifier Source: org_study_id