Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw - Full Text View

Sponsored by:	Astra Tech AB
Information provided by:	Astra Tech AB
ClinicalTrials.gov Identifier:	NCT00820235

Purpose

The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.

Condition	Intervention
Jaw, Edentulous, Partially	Device: OsseoSpeed™ Device: NobelSpeedy™ Replace® Device: NanoTite™ Certain® PREVAIL®

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Prospective, Comparative Assessment of Single-Tooth Replacement in Different Implant-Abutment Settings

Further study details as provided by Astra Tech AB:

Primary Outcome Measures:

Buccal soft tissue (gum) changes [ Time Frame: 3-4 weeks (baseline), 12 weeks and 6, 12, 24 and 36 months after implant placement ] [ Designated as safety issue: No ]

Estimated Enrollment:	144
Study Start Date:	January 2009
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Device: OsseoSpeed™ OsseoSpeed™ implant
B: Active Comparator	Device: NobelSpeedy™ Replace® NobelSpeedy™ Replace® implant
C: Active Comparator	Device: NanoTite™ Certain® PREVAIL® NanoTite™ Certain® PREVAIL® implant

Eligibility

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

Criteria

Inclusion Criteria:

Provision of informed consent
At least 18 years
In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24

The following should be considered at inclusion but can not be fulfilled until at Visit 2:

Edentulous for at least 5 months at study site
A buccal-lingual bone width at study site of at least 5.5 mm
A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm
A keratinized mid-buccal mucosal height of at least 2 mm at study site
Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (>1 mm) and/or significant soft tissue loss
Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions
An opposing dentition with teeth, implants or prosthesis

Exclusion Criteria:

Insufficient interocclusal distance for implant placement and restoration at study site
Tooth adjacent (mesial and/or distal) to study site is ankylosed
More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth
Site development (bone tissue) performed at less than 5 months before Visit 2 at study site
Untreated rampant caries and/or uncontrolled periodontal disease
Class II division 2 malocclusion (Edward Hartley Angle)
Use of tobacco within last 6 months
Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent/non-insulin dependent Diabetes Mellitus)
Current alcohol or drug abuse
Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
Use of any substance that will influence bone metabolism
Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
History of radiation in the head and neck region
Known pregnancy, pregnancy tests will be performed as per local requirements.
Unable or unwilling to return for follow-up visits for a period of 3 years
Unlikely to be able to comply with study procedures according to Investigators judgement
Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study center)
Previous enrollment or randomization of treatment in the present study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820235

Contacts

Contact: Ann-Sofie Andersson

+46317763000

Locations

United States, Iowa
University of Iowa, College of Dentistry
Iowa City, Iowa, United States, 52242-1010
United States, North Carolina
University of North Carolina, School of Dentistry
Chapel Hill, North Carolina, United States, 27599-7450
United States, Texas
Perio Health Clinical Research Center
Houston, Texas, United States, 77063
Canada, Quebec
Faculty of Dentistry, McGill University
Montreal, Quebec, Canada, H3A 2K6

Sponsors and Collaborators

Astra Tech AB

Investigators

Study Director:

Lyndon Cooper, Prof.

University of North Carolina, School of Dentistry

More Information

Responsible Party:	Astra Tech AB ( Head of Clinical Research Area Dental )
Study ID Numbers:	YA-OSS-0003
Study First Received:	January 9, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00820235
Health Authority:	Canada: Ethics Review Committee; United States: Institutional Review Board

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:

Jaw Diseases

ClinicalTrials.gov processed this record on January 16, 2009