NCT00710944CompletedNot Applicable
An Open, Prospective, Controlled Study in the Maxilla to Evaluate Clinical Outcome of ASTRA TECH Implant System, OsseoSpeed™ Implants in Single Tooth Replacement Using an Immediate Loading Protocol in Extraction Sockets and Healed Ridges.
Dentsply Sirona Implants and Consumables8 sites in 4 countries132 target enrollmentStarted: April 1, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 132
- Locations
- 8
- Primary Endpoint
- Implant Survival
Study Overview
Brief Summary
The purpose of this study is to evaluate survival for ASTRA TECH Implant System, OsseoSpeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. Patients in need of single standing implants replacing teeth in the maxilla within zone 15-25 will be included and followed for 5 years. Primary objective is implant survival rate at 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of written informed consent
- •18 years of age and over
- •A minimum of 20 stable intra occlusal contacts after planned restoration
- •In need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25
Exclusion Criteria
- •Untreated rampant caries and uncontrolled periodontal disease
- •Use of smoking tobacco at time of inclusion
- •History of pre-surgical bone augmentation, within 4 months, in the planned implant area
- •History of extraction without augmentation, within 3 months in the planned implant area
- •Absence of opposing dentition
- •Absence of adjacent (mesial and/or distal) natural tooth
- •Uncontrolled diabetes
- •Known pregnancy at time of inclusion
- •Present alcohol or drug abuse
- •Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- •Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- •Unable or unwilling to return for follow-up visits for a period of 5 years
- •Unrealistic esthetical demands
- •Unlikely to be able to comply with study procedures according to Investigators judgment
- •Already included in this study
Outcomes
Primary Outcomes
Implant Survival
Time Frame: 12 months after implant placement
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (8)
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