Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00710944
First received: July 7, 2008
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate survival for ASTRA TECH Implant System, 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: ASTRA TECH Implant System, 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 Implant System, OsseoSpeed™ Implants 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: 12 months after implant placement ] [ Designated as safety issue: No ]
    An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.


Enrollment: 132
Study Start Date: April 2005
Study Completion Date: November 2012
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extraction Sockets
Immediate loading in extraction sockets.
Device: ASTRA TECH Implant System, OsseoSpeed™
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
Experimental: Healed Ridges
Immediate loading in healed ridges.
Device: ASTRA TECH Implant System, OsseoSpeed™
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
Experimental: Grafted Sites
Immediate loading of implants placed in grafted sites (four months healing after grafting).
Device: ASTRA TECH Implant System, OsseoSpeed™
ASTRA TECH Implant System, OsseoSpeed™: 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
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: 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
Results First Received: March 12, 2014
Last Updated: June 26, 2014
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 August 01, 2014