An Open, Prospective Study to Evaluate Implant Stability, Marginal Bone Adaptation and the Survival Rate of Astra Tech Dental Implant System, Fixture Osseospeed™, in Patients With Tooth Loss in the Posterior Maxilla in an Early Loading Protocol.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 47
- Locations
- 6
- Primary Endpoint
- Implant Survival Rate
Study Overview
Brief Summary
The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- 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
- •Edentulous in the posterior maxilla, Kennedy classes I or II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
- •Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading
Exclusion Criteria
- •Untreated caries and/or periodontal disease of residual dentition
- •History of edentulism in the area of implant placement of less than two months
- •Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
- •History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
- •Sinus floor thickness of less than 5 mm, verified by periapical radiographs.
- •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
- •Present alcohol or drug abuse
- •Unable or unwilling to return for follow-up visits for a period of 5 years
- •Current use of smoking tobacco
- •Pregnancy or lactation at the time of enrollment
Outcomes
Primary Outcomes
Implant Survival Rate
Time Frame: At 5 year follow-up
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.
Implant Stability
Time Frame: At 1 year follow-up
Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (\<60) indicate low stability, medium values (60-70) indicate medium stability and high values (\>70) indicate high stability.
Marginal Bone Adaptation
Time Frame: At baseline (loading) and at 5 year follow-up
Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.
Secondary Outcomes
No secondary outcomes reported