Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours

NCT ID: NCT00711022

Last Updated: 2014-07-16

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of the study is to evaluate ASTRA TECH Implant System, OsseoSpeed™ implants, in patients with totally edentulous upper jaws and poor bone quality and quantity, when provisional artificial teeth are attached within 24 hours. The primary objective is to investigate implant survival rate.

Detailed Description

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Conditions

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Jaw, Edentulous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OsseoSpeed

Group Type EXPERIMENTAL

ASTRA TECH Implant System, OsseoSpeed™, all dimensions.

Intervention Type DEVICE

Interventions

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ASTRA TECH Implant System, OsseoSpeed™, all dimensions.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent
* Aged 20 years and over
* History of totally edentulous maxilla of at least three months
* Radiographic finding indicating bone quality class 3 or 4 (Lekholm and Zarb) in the maxilla
* Radiographic finding indicating bone quantity class C, D or E (Lekholm and Zarb) in the maxilla
* Presence of natural teeth, partial prosthesis and/or implants in the mandible, within positions 35-45 (according to the FDI digit system)
* Deemed by the investigator as likely to present an initially stable implant situation suitable for immediate loading.

Exclusion Criteria

* Unlikely to be able to comply with study procedures, as judged by the investigator
* Uncontrolled pathologic processes in the oral cavity
* Known or suspected current malignancy
* History of radiation in the head and neck region
* History of chemotherapy within 5 years prior to surgery
* Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Uncontrolled Diabetes Mellitus
* Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* History of bone augmentation in the maxilla within 6 months prior to surgery
* Known pregnancy at time of enrolment
* Present alcohol and/or drug abuse
* Current use of tobacco or history of tobacco use within 6 months prior to surgery
* Need for interpreter
Minimum Eligible Age

20 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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Joseph A Toljanic, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago, MC-2108

Chicago, Illinois, United States

Site Status

Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine

Uppsala, , Sweden

Site Status

Countries

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United States Sweden

References

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Toljanic JA, Baer RA, Ekstrand K, Thor A. Implant rehabilitation of the atrophic edentulous maxilla including immediate fixed provisional restoration without the use of bone grafting: a review of 1-year outcome data from a long-term prospective clinical trial. Int J Oral Maxillofac Implants. 2009 May-Jun;24(3):518-26.

Reference Type RESULT
PMID: 19587876 (View on PubMed)

Erkapers M, Ekstrand K, Baer RA, Toljanic JA, Thor A. Patient satisfaction following dental implant treatment with immediate loading in the edentulous atrophic maxilla. Int J Oral Maxillofac Implants. 2011 Mar-Apr;26(2):356-64.

Reference Type RESULT
PMID: 21483889 (View on PubMed)

Thor A, Ekstrand K, Baer RA, Toljanic JA. Three-year follow-up of immediately loaded implants in the edentulous atrophic maxilla: a study in patients with poor bone quantity and quality. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):642-9. doi: 10.11607/jomi.3163.

Reference Type RESULT
PMID: 24818203 (View on PubMed)

Erkapers M, Segerstrom S, Ekstrand K, Baer RA, Toljanic JA, Thor A. The influence of immediately loaded implant treatment in the atrophic edentulous maxilla on oral health related quality of life of edentulous patients: 3-year results of a prospective study. Head Face Med. 2017 Nov 10;13(1):21. doi: 10.1186/s13005-017-0154-0.

Reference Type DERIVED
PMID: 29126426 (View on PubMed)

Other Identifiers

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YA-OSS-0008

Identifier Type: -

Identifier Source: org_study_id

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