Status:
COMPLETED
Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface
Lead Sponsor:
Institut Straumann AG
Conditions:
Partial Edentulism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ev...
Eligibility Criteria
Inclusion
- 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
- 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
- Use of any investigational drug or device within the 30 day period immediately prior to implant surgery on study day 0
- Alcoholism or drug abuse
- Patients infected with HIV
- Patients who smoke \>10 cigarettes per day or cigar equivalents, or who chew tobacco
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability
- Local inflammation, including untreated periodontitis
- Mucosal diseases such as erosive lichen planus
- History of local irradiation therapy
- Presence of osseous lesions
- Unhealed extraction sites (less than 4 months post extraction of teeth in intended sites)
- Bone surgery (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement and the site fully healed. Note: Minor bone enhancement using harvested bone from the implant site and a resorbable membrane is allowed at the time of implant placement
- Patients requiring bone grafting at the surgical sites at the time of surgery.
- Severe bruxing or clenching habits
- Persistent intraoral infection
- Lack of primary stability of one (or more) implant(s) at surgery. In this instance the patient must be withdrawn and the patient treated accordingly
- Patients with inadequate oral hygiene or unmotivated for adequate home care
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT00782171
Start Date
July 1 2004
End Date
February 1 2010
Last Update
June 20 2017
Active Locations (19)
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1
Private Practice
Boca Raton, Florida, United States, 33431
2
Private Practice
Indianapolis, Indiana, United States, 46280
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Tiroler Landeskrankenanstaltengesellschaft mbH
Innsbruck, Austria