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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00807456
Recruitment Status : Completed
First Posted : December 12, 2008
Results First Posted : May 30, 2016
Last Update Posted : May 30, 2016
Information provided by (Responsible Party):
Dentsply Sirona Implants

December 11, 2008
December 12, 2008
March 16, 2016
May 30, 2016
May 30, 2016
November 2008
June 2013   (Final data collection date for primary outcome measure)
Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to 16 Weeks After Implant Placement [ Time Frame: At baseline and 16 weeks ]
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.
Lingual bone level alteration [ Time Frame: At baseline and 16 weeks ]
Complete list of historical versions of study NCT00807456 on Archive Site
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Marginal Bone Level [ Time Frame: At baseline, 21 wks, 1, 2, 3 yrs ]
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Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone
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

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.

Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Experimental: ASTRA TECH Implant System, OsseoSpeed™
Intervention: Device: ASTRA TECH Implant System, OsseoSpeed™
Noelken R, Donati M, Fiorellini J, Gellrich NC, Parker W, Wada K, Berglundh T. Soft and hard tissue alterations around implants placed in an alveolar ridge with a sloped configuration. Clin Oral Implants Res. 2014 Jan;25(1):3-9. doi: 10.1111/clr.12079. Epub 2012 Dec 5.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   United States
Not Provided
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Dentsply Sirona Implants
Dentsply Sirona Implants
Not Provided
Study Chair: Tord Berglundh, Prof. Department of Periodontology, Sahlgrenska Academy at University of Gothenburg
Dentsply Sirona Implants
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP