Status:
COMPLETED
Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone
Lead Sponsor:
Dentsply Sirona Implants and Consumables
Conditions:
Edentulism
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 ling...
Eligibility Criteria
Inclusion
- Provision of informed consent
- Aged 18-75 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
- 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 Sponsor staff or staff at the study site)
- Unlikely to be able to comply with study procedures, as judged by the investigator
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00807456
Start Date
November 1 2008
End Date
December 1 2013
Last Update
November 17 2022
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Periodontology, College of Dental Medicine, Nova Southeastern University
Fort Lauderdale, Florida, United States, 33328-2018
2
Department of Periodontics, Robert Schattner Center, School of Dental Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
Medizinische Hochschule Hannover
Hanover, Germany, D-30625
4
Praxis Dr Robert Nölken
Lindau, Germany, D-88131