Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface

Completed · Phase 4

Conditions studied: Partial Edentulism

In brief

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

Key facts

Study ID

NCT00782171

Run by

Institut Straumann AG

People needed

266

Starts

2004-07-01

Expected to finish

2010-02-01

Last updated by the study team

2017-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Private Practice — Boca Raton, Florida, United States
• Private Practice — Indianapolis, Indiana, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Tiroler Landeskrankenanstaltengesellschaft mbH — Innsbruck, Austria
• Praxisklinik fur Mund- Keifer- und Gesichtschirurgie — Bochum, Germany
• Private Practice — Fürth, Germany
• Klinikum Nord-Heidberg — Hamburg, Germany
• Private Practice — Weiden, Germany
• Private Universitat Witten — Witten, Germany
• Queens University — Belfast, Ireland
• Dublin Dental Hospital — Dublin, Ireland
• Rijnland Hospital — Leiderdorp, Netherlands
• Faculdade de medicina de coimbra — Coimbra, Portugal
• Private Practice — Porto, Portugal
• Private Practice — Barcelona, Spain
• Private Practice — Málaga, Spain
• Clinica Periobalear — Palma de Mallorca, Spain
• Private Practice — Falun, Sweden
• Private Practice — Sankt Gallen, Switzerland

Full record on ClinicalTrials.gov

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