Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone
This study is ongoing, but not recruiting participants.
Sponsor:
Dentsply Implants
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00807456
First received: December 11, 2008
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
The study aims to evaluate maintenance of lingual/palatinal marginal bone with the 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: 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 OsseoSpeed™ Profile Implant. A 3-year Follow-up Study |
Further study details as provided by Dentsply Implants:
Primary Outcome Measures:
- Lingual bone level alteration [ Time Frame: At baseline and 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Marginal Bone Level [ Time Frame: At baseline, 21 wks, 1, 2, 3 yrs ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Device: OsseoSpeed™
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 |
| 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
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
No publications provided
| Responsible Party: | Dentsply Implants |
| ClinicalTrials.gov Identifier: | NCT00807456 History of Changes |
| Other Study ID Numbers: | YA-PRO-0001 |
| Study First Received: | December 11, 2008 |
| Last Updated: | February 25, 2013 |
| Health Authority: | Germany: Ethics Commission Italy: Ethics Committee Sweden: Regional Ethical Review Board United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 23, 2013