Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00807456
First received: December 11, 2008
Last updated: April 26, 2016
Last verified: April 2016
  Purpose

The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) 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: ASTRA TECH Implant System, 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 ASTRA TECH Implant System, OsseoSpeed™ Profile Implant. A 3-year Follow-up Study

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to 16 Weeks After Implant Placement [ Time Frame: At baseline and 16 weeks ] [ Designated as safety issue: No ]
    Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant (the rim (R), i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.


Enrollment: 65
Study Start Date: November 2008
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASTRA TECH Implant System, OsseoSpeed™ Device: ASTRA TECH Implant System, OsseoSpeed™
ASTRA TECH Implant System, 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   (Adult, Senior)
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
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: 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
Dentsply Implants
Investigators
Study Chair: Tord Berglundh, Prof. Department of Periodontology, Sahlgrenska Academy at University of Gothenburg
  More Information

Publications:
Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00807456     History of Changes
Other Study ID Numbers: YA-PRO-0001 
Study First Received: December 11, 2008
Results First Received: March 16, 2016
Last Updated: April 26, 2016
Health Authority: Germany: Ethics Commission
Italy: Ethics Committee
Sweden: Regional Ethical Review Board
United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 26, 2016