Status:
COMPLETED
Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses
Lead Sponsor:
Dentsply International
Conditions:
Edentulism
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Change in crestal bone level implants at 5% significance level.
Eligibility Criteria
Inclusion
- age 18 to 80
- male or female (female non-pregnant)
- sufficient oral hygiene
- no inflammation/disorder in the area of implant site
- edentulous mandible and sufficient prosthetic and conservative
- sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm
- provide written informed consent
Exclusion
- demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas
- exhibit angulation requirements of restoration exceeding 15 degrees
- systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration
- taking medication that would compromise post-operative healing and/or osseointegration
- bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus
- oncology treatment
- oral infection
- acute gingivitis and/or periodontitis
- local bone defects in the area of planned implantation
- disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions)
- received investigational drug within 30 days
- history of illicit drugs or alcohol abuse
- history of addiction to medication
- allergic to dental materials
- nicotine abuse (\> 20 cigarettes/day)
- pregnant or nursing
- clinical significant or unstable medical or physiological conditions that would compromise participation in study
- unable or unwilling to return for follow-up visits for a period of 24 months
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00780273
Start Date
September 1 2008
End Date
April 1 2012
Last Update
August 19 2014
Active Locations (1)
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1
University of Rochester, Eastman Dept of Dentistry
Rochester, New York, United States, 14620