Study to Compare Survival for Microthread™ OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges

This study is ongoing, but not recruiting participants.

First Received: July 7, 2008 Last Updated: January 8, 2009 History of Changes

Sponsored by:	Astra Tech AB
Information provided by:	Astra Tech AB
ClinicalTrials.gov Identifier:	NCT00710944

Purpose

The purpose of this study is to evaluate survival for Microthread™ OsseoSpeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. Patients in need of single standing implants replacing teeth in the maxilla within zone 15-25 will be included and followed for 5 years. Primary objective is implant survival rate at 12 months.

Condition	Intervention
Jaw, Edentulous, Partially	Device: OsseoSpeed™

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	An Open, Prospective, Controlled Study in the Maxilla to Evaluate Clinical Outcome of Astra Tech Implants, Fixture Microthread™ OsseoSpeed™ in Single Tooth Replacement Using an Immediate Loading Protocol in Extraction Sockets and Healed Ridges.

Further study details as provided by Astra Tech AB:

Primary Outcome Measures:

Implant survival [ Time Frame: During 12 months after implant placement ] [ Designated as safety issue: No ]

Enrollment:	112
Study Start Date:	April 2005
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Immediate loading in extraction sockets.	Device: OsseoSpeed™ OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
B: Experimental Immediate loading in healed ridges.	Device: OsseoSpeed™ OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of written informed consent
18 years of age and over
A minimum of 20 stable intra occlusal contacts after planned restoration
In need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25

Exclusion Criteria:

Untreated rampant caries and uncontrolled periodontal disease
Use of smoking tobacco at time of inclusion
History of pre-surgical bone augmentation, within 4 months, in the planned implant area
History of extraction without augmentation, within 3 months in the planned implant area
Absence of opposing dentition
Absence of adjacent (mesial and/or distal) natural tooth
Uncontrolled diabetes
Known pregnancy at time of inclusion
Present alcohol or drug abuse
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
Unable or unwilling to return for follow-up visits for a period of 5 years
Unrealistic esthetical demands
Unlikely to be able to comply with study procedures according to Investigators judgment
Already included in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710944

Locations

United States, North Carolina
School of Dentistry
Chapel Hill, North Carolina, United States, 27599-7450
Belgium
Dental School Department Periodontology
Ghent, Belgium, B-9000
Germany
Department of Oromaxillofacial Surgery, Hospital of the Christian- Albrechts University at Kiel
Kiel, Germany, 241 05
Spain
Universitat Internacional de Catalunya, Department de Odontología
Barcelona, Spain, 08190

Sponsors and Collaborators

Astra Tech AB

Investigators

Principal Investigator:

Lyndon Cooper, Prof, DDS, PhD

School of Dentistry, Chapel Hill

More Information

No publications provided

Responsible Party:	Astra Tech AB ( Head of Therapeutic Area Dental, Clinical Research )
Study ID Numbers:	YA-OSS-0006
Study First Received:	July 7, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00710944 History of Changes
Health Authority:	United States: Institutional Review Board; Belgium: Institutional Review Board; Germany: Ethics Commission; Spain: Comité Ético de Investigación Clínica

Keywords provided by Astra Tech AB:

Jaw, Edentulous, Partially (missing/extracted/avulsed teeth in the maxilla within zone 15(4)-25(13))

Study placed in the following topic categories:

Mouth Diseases
Mouth, Edentulous
Tooth Diseases
Musculoskeletal Diseases

Stomatognathic Diseases
Jaw, Edentulous
Jaw, Edentulous, Partially

Additional relevant MeSH terms:

Mouth Diseases
Mouth, Edentulous
Tooth Diseases
Musculoskeletal Diseases

Jaw Diseases
Stomatognathic Diseases
Jaw, Edentulous
Jaw, Edentulous, Partially

ClinicalTrials.gov processed this record on May 07, 2009