Partial Edentulism Clinical Trial
Official title:
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
The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.
Status | Completed |
Enrollment | 285 |
Est. completion date | February 2010 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Tiroler Landeskrankenanstaltengesellschaft mbH | Innsbruck | |
Germany | Praxisklinik fur Mund- Keifer- und Gesichtschirurgie | Bochum | |
Germany | Private Practice | Furth | |
Germany | Klinikum Nord-Heidberg | Hamburg | |
Germany | Private Practice | Weiden | |
Germany | Private Universitat Witten | Witten | |
Ireland | Queens University | Belfast | |
Ireland | Dublin Dental Hospital | Dublin | |
Netherlands | Rijnland Hospital | Leiderdorp | |
Portugal | Faculdade de medicina de coimbra | Coimbra | |
Portugal | Private Practice | Oporto | |
Spain | Private Practice | Barcelona | |
Spain | Private Practice | Malaga | |
Spain | Clinica Periobalear | Palma de Mallorca | |
Sweden | Private Practice | Falun | |
Switzerland | Private Practice | St. Gallen | |
United States | Private Practice | Boca Raton | Florida |
United States | Private Practice | Indianapolis | Indiana |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Institut Straumann AG |
United States, Austria, Germany, Ireland, Netherlands, Portugal, Spain, Sweden, Switzerland,
Ganeles J, Zöllner A, Jackowski J, ten Bruggenkate C, Beagle J, Guerra F. Immediate and early loading of Straumann implants with a chemically modified surface (SLActive) in the posterior mandible and maxilla: 1-year results from a prospective multicenter — View Citation
Nicolau P, Korostoff J, Ganeles J, Jackowski J, Krafft T, Neves M, Divi J, Rasse M, Guerra F, Fischer K. Immediate and early loading of chemically modified implants in posterior jaws: 3-year results from a prospective randomized multicenter study. Clin Im — View Citation
Zöllner A, Ganeles J, Korostoff J, Guerra F, Krafft T, Brägger U. Immediate and early non-occlusal loading of Straumann implants with a chemically modified surface (SLActive) in the posterior mandible and maxilla: interim results from a prospective multic — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of changes in crestal bone levels evaluated from standardized periapical x-rays comparing the immediate and delayed loading procedures in each group. | 20-23 Weeks | No | |
Secondary | Implant success and survival | 20-23 Weeks | No | |
Secondary | Implant success and survival | 1, 2, and 3 Years | No | |
Secondary | Performance of restorative components | 1, 2, and 3 Years | No | |
Secondary | Nature and frequency of adverse events | All time points | No |
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