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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 Sirona Implants
ClinicalTrials.gov Identifier:
NCT00807456
First received: December 11, 2008
Last updated: April 26, 2016
Last verified: April 2016

December 11, 2008
April 26, 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 ] [ 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.
Lingual bone level alteration [ Time Frame: At baseline and 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00807456 on ClinicalTrials.gov Archive Site
Not Provided
Marginal Bone Level [ Time Frame: At baseline, 21 wks, 1, 2, 3 yrs ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Edentulism
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
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
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Italy
Sweden
 
NCT00807456
YA-PRO-0001
No
Not Provided
Not Provided
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