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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00782171
Other study ID # CR 06/03
Secondary ID
Status Completed
Phase Phase 4
First received October 28, 2008
Last updated June 6, 2012
Start date July 2004
Est. completion date February 2010

Study information

Verified date June 2012
Source Institut Straumann AG
Contact n/a
Is FDA regulated No
Health authority Austria: EthikkommissionGermany: Ethics CommissionIreland: Medical Ethics Research CommitteeNetherlands: Independent Ethics CommitteePortugal: Ethics Committee for Clinical ResearchSpain: Ethics CommitteeSweden: Institutional Review BoardSwitzerland: EthikkommissionUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
SLActive dental implant
Immediate restoration or early restoration (4 weeks)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Institut Straumann AG

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Ireland,  Netherlands,  Portugal,  Spain,  Sweden,  Switzerland, 

References & Publications (3)

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

Outcome

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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