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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00710944
First received: July 7, 2008
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  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™

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Dentsply Implants:

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: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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.
Experimental: B
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
Dentsply Implants
Investigators
Principal Investigator: Lyndon Cooper, Prof, DDS, PhD School of Dentistry, Chapel Hill
  More Information

Publications:

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00710944     History of Changes
Other Study ID Numbers: YA-OSS-0006
Study First Received: July 7, 2008
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board
Belgium: Institutional Review Board
Germany: Ethics Commission
Spain: Comité Ético de Investigación Clínica

Keywords provided by Dentsply Implants:
Jaw, Edentulous, Partially (missing/extracted/avulsed teeth in the maxilla within zone 15(4)-25(13))

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 May 16, 2013