Study of Bone Preservation When OsseoSpeed™ Implants Are Placed Immediately Following Tooth Extraction - Full Text View

Sponsor:	Astra Tech AB
Information provided by (Responsible Party):	Astra Tech AB
ClinicalTrials.gov Identifier:	NCT00711282

Purpose

The purpose of this study is to evaluate the clinical performance of implants placed in individuals who are about to loose one or more of their upper teeth. The main objective is to study how the surrounding bone tissue reacts to two different shapes of implants. Clinical performance, in wider terms, means esthetics and long lasting function. Half of the patients will receive a cylindrically shaped implant and the other half will receive a conical-cylindrical implant. The implants will be placed and after a healing period of 16 weeks the gum will be re-opened and the bone tissue response clinically evaluated. Permanent artificial tooth/teeth will be attached six weeks after that.

Condition	Intervention
Jaw, Edentulous, Partially	Device: OsseoSpeed™

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Randomized, Controlled Study to Evaluate Buccal Bone Preservation Using Fixture MicroThread™ OsseoSpeed™ Placed in Fresh Extraction Sockets the Maxilla.

Further study details as provided by Astra Tech AB:

Primary Outcome Measures:

Clinical measure of the thickness of the facial bone wall. [ Time Frame: At implant placement and after 16 weeks of healing. ] [ Designated as safety issue: No ]

Enrollment:	104
Study Start Date:	December 2005
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Device: OsseoSpeed™ OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.
Experimental: B	Device: OsseoSpeed™ OsseoSpeed™ MicroThread™, diameters of 4.5 and 5.0 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
At least 18 years at inclusion
At least 20 teeth with expected functional balanced occlusion after restoration
In need of one or more implants replacing teeth to be removed in the maxilla within region 15 to 25
Presence of an intact extraction socket following removal of the natural tooth defined by: (1) a situation where the marginal border of the facial bone crest deviates less than or equal to 2 mm from that of the expected normal anatomy of the site/region, (2) a marginal border of a potential facial fenestration at least 3 mm apical of the marginal bone crest
Presence of an extraction socket anatomy, following removal of the natural tooth, suitable for both cylindrical and conical/cylindrical implants

Exclusion Criteria:

Untreated rampant caries and uncontrolled periodontal disease
Absence of adjacent (mesial and/or distal) natural tooth root
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
Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
History of radiation in the head and neck region
History of chemotherapy within 5 years prior to surgery
Unable or unwilling to return for follow-up visits for a period of 3 years and 6 months
Unrealistic esthetic demands
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 investigational site)
Previous enrolment in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711282

Locations

Italy
Studio Odontoiatrico
Padova, Italy, 351 25
Spain
Department of Periodontics, Faculty of Odontology, Universidad Complutense de Madrid
Madrid, Spain, 28040
Switzerland
Department of Periodontology, School of Dental Medicine, University of Berne
Berne, Switzerland, CH-3010

Sponsors and Collaborators

Astra Tech AB

More Information

Publications:

Huynh-Ba G, Pjetursson BE, Sanz M, Cecchinato D, Ferrus J, Lindhe J, Lang NP. Analysis of the socket bone wall dimensions in the upper maxilla in relation to immediate implant placement. Clin Oral Implants Res. 2010 Jan;21(1):37-42.

Tomasi C, Sanz M, Cecchinato D, Pjetursson B, Ferrus J, Lang NP, Lindhe J. Bone dimensional variations at implants placed in fresh extraction sockets: a multilevel multivariate analysis. Clin Oral Implants Res. 2010 Jan;21(1):30-6.

Sanz M, Cecchinato D, Ferrus J, Pjetursson EB, Lang NP, Lindhe J. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla. Clin Oral Implants Res. 2010 Jan;21(1):13-21. Epub 2009 Nov 18.

Ferrus J, Cecchinato D, Pjetursson EB, Lang NP, Sanz M, Lindhe J. Factors influencing ridge alterations following immediate implant placement into extraction sockets. Clin Oral Implants Res. 2010 Jan;21(1):22-9. Epub 2009 Nov 13.

Responsible Party:	Astra Tech AB
ClinicalTrials.gov Identifier:	NCT00711282 History of Changes
Other Study ID Numbers:	YA-OSS-0009
Study First Received:	July 7, 2008
Last Updated:	September 27, 2011
Health Authority:	Italy: Ethics Committee; Spain: Comité Ético de Investigación Clínica; Switzerland: Ethikkommission

Keywords provided by Astra Tech AB:

Replacement of non-restorable single tooth/teeth

Additional relevant MeSH terms:

Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Jaw Diseases

Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on February 12, 2012