An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Jaw, Edentulous, Partially
- Sponsor
- Dentsply Sirona Implants and Consumables
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Marginal Bone Level Changes
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of written informed consent
- •Age 18 - 75 years
- •Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
- •Edentulous in the area/s if implant placement for more than 2 months
Exclusion Criteria
- •Untreated caries and/or periodontal disease of residual dentition
- •Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
- •Absence of occlusal stability in centric occlusion
- •Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- •Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- •Pregnancy
- •Present alcohol or drug abuse
- •Tobacco smoking during the last 6 months
- •Unable or unwilling to return for follow-up visits for a period of 3 years
Outcomes
Primary Outcomes
Marginal Bone Level Changes
Time Frame: 3 years after implant placement (baseline)
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 the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.