Study of Bone Preservation When OsseoSpeed™ Implants Are Placed Immediately Following Tooth Extraction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00711282
First received: July 7, 2008
Last updated: June 26, 2014
Last verified: June 2014
  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 Dentsply Implants:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dentsply Implants
  More Information

Publications:

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00711282     History of Changes
Other Study ID Numbers: YA-OSS-0009
Study First Received: July 7, 2008
Last Updated: June 26, 2014
Health Authority: Italy: Ethics Committee
Spain: Comité Ético de Investigación Clínica
Switzerland: Ethikkommission

Keywords provided by Dentsply Implants:
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 July 23, 2014