Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses
Phase 4
Completed
- Conditions
- Edentulism
- Registration Number
- NCT00780273
- Lead Sponsor
- Dentsply International
- Brief Summary
Change in crestal bone level implants at 5% significance level.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level 24 months after surgery Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Rochester, Eastman Dept of Dentistry
🇺🇸Rochester, New York, United States
University of Rochester, Eastman Dept of Dentistry🇺🇸Rochester, New York, United States