Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone - Full Text View

Sponsor:	Astra Tech AB
Information provided by (Responsible Party):	Astra Tech AB
ClinicalTrials.gov Identifier:	NCT00807456

Purpose

The study aims to evaluate maintenance of lingual/palatinal marginal bone with the OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction.

The hypothesis is that the sloped marginal contour of the implant will help preserve the lingual/palatinal marginal bone.

Condition	Intervention
Edentulism	Device: OsseoSpeed™

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Open, Single Arm, Multi-center Study to Evaluate Maintenance of Lingual Bone in Healed Ridges With the OsseoSpeed™ Profile Implant. A 3-year Follow-up Study

Further study details as provided by Astra Tech AB:

Primary Outcome Measures:

Lingual bone level alteration [ Time Frame: At baseline and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Marginal Bone Level [ Time Frame: At baseline, 21 wks, 1, 2, 3 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	November 2008
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Device: OsseoSpeed™ OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of informed consent
Aged 18-70 years at enrolment
A lingual-buccal difference in bone height between 2.0-5.0 mm at the implant site
History of edentulism in the study area of at least 3 months
Presence of alveolar bone crest dimensions judged by the investigator to allow >1mm of bone circumferential to the implant after implant placement.
In need for a single implant replacing a missing tooth in any location with an adjacent natural tooth mesially, and an adjacent natural tooth or edentulous space distally to the planned implant position (i.e. no existing or planned implant adjacent to the planned study implant position)
Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

Uncontrolled pathological processes in the oral cavity
Known or suspected current malignancy
History of radiation therapy 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
Smoking more than 10 cigarettes per day
Present alcohol and/or drug abuse
Current need for bone grafting in the planned implant area
Previous enrolment in the present study
Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months
Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
Unlikely to be able to comply with study procedures, as judged by the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807456

Locations

United States, Florida
Department of Periodontology, College of Dental Medicine, Nova Southeastern University
Fort Lauderdale, Florida, United States, 33328-2018
United States, Pennsylvania
Department of Periodontics, Robert Schattner Center, School of Dental Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Germany
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Praxis Dr Robert Nölken
Lindau, Germany, D-88131
Italy
Studio Dentistico Donati
Perugia, Italy, IT-06121

Sponsors and Collaborators

Astra Tech AB

Investigators

Study Chair:

Tord Berglundh, Prof.

Department of Periodontology, Sahlgrenska Academy at University of Gothenburg

More Information

No publications provided

Responsible Party:	Astra Tech AB
ClinicalTrials.gov Identifier:	NCT00807456 History of Changes
Other Study ID Numbers:	YA-PRO-0001
Study First Received:	December 11, 2008
Last Updated:	September 23, 2011
Health Authority:	Germany: Ethics Commission Italy: Ethics Committee Sweden: Regional Ethical Review Board United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2012