Immediate and Delayed Loading of 4.1 mm and 4.8 mm Implants in the Posterior Mandible & Maxilla: A Controlled Randomized Study of Single or 2-4 Unit Restorations Loaded Immediately After Surgery or Four Weeks After Surgery
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Partial Edentulism
- Sponsor
- Institut Straumann AG
- Enrollment
- 266
- Locations
- 11
- Primary Endpoint
- Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.
Detailed Description
This study is a post-market randomized study whereby each patient will receive 1 to 4 implants placed in the posterior maxilla or mandible. The primary objective of this randomized open study is to evaluate the performance in immediate and delayed loading (4 weeks) of Straumann standard solid screw 4.1mm and the 4.8 mm diameter wide neck implants with a new surface. These implants will support single crowns or 2 to 4 unit bridge restorations in the posterior maxilla or mandible and the treatment will be evaluated for the immediate and delayed loading procedures at one year post surgery. Patients will be allocated into two groups and then randomized into immediate or delayed loading arms.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females must be at least 18 years of age
- •Have at least one missing tooth in positions FDI 4, 5, 6, or 7 in any quadrant (ADA positions 2, 3, 4, 5; or 12, 13, 14, 15; or 20, 21, 22, 23; or 28, 29, 30, 31.)
- •Subjects desire an implant supported restoration on1 to 4 implants per quadrant
- •The tooth/teeth position(s) at the proposed implant site must have been extracted or lost at least 4 months before the date of implantation and be fully healed
- •Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann standard 4.1 mm diameter implant of at least 8 mm length without the use of concurrent bone augmentation techniques. If more bone is available and is indicated a Straumann standard 4.8 mm diameter implant with a wide neck of at least 8 mm length may be used, i.e. implant insertion sites must have sufficient bone height such that the implant will not encroach on vital structures and sufficient width that a minimum of 1 mm of bone lingual and buccal bone will remain
- •The opposing dentition must be natural teeth or fixed crowns or bridges on natural teeth or implants. Removable prostheses or dentures opposing the study implants are not allowed
- •Patients must be committed to the study for its full duration.
Exclusion Criteria
- •Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements)
- •Medical conditions requiring prolonged use of steroids
- •History of leukocyte dysfunction and deficiencies
- •History of bleeding disorders
- •History of neoplastic disease requiring the use of chemotherapy
- •History of radiation therapy to the head and neck
- •Patients with history of renal failure
- •Patients with severe or uncontrolled metabolic bone disorders
- •Uncontrolled endocrine disorders
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene
Outcomes
Primary Outcomes
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
Time Frame: Change in crestal bone level from surgery (baseline) to 3 years post-surgery
Secondary Outcomes
- Implant Survival(3 years post-surgery)
- Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events(until the 3 year post-surgery)
- Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected(until the 3 year post-surgery)
- Implant Success(3 years post-surgery)