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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00782171
First received: October 28, 2008
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Partial Edentulism
Device: SLActive dental implant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • 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: 20-23 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implant success and survival [ Time Frame: 20-23 Weeks ] [ Designated as safety issue: No ]
  • Implant success and survival [ Time Frame: 1, 2, and 3 Years ] [ Designated as safety issue: No ]
  • Performance of restorative components [ Time Frame: 1, 2, and 3 Years ] [ Designated as safety issue: No ]
  • Nature and frequency of adverse events [ Time Frame: All time points ] [ Designated as safety issue: No ]

Enrollment: 285
Study Start Date: July 2004
Study Completion Date: February 2010
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate restoration Device: SLActive dental implant
Immediate restoration or early restoration (4 weeks)
Other Name: SLActive
Active Comparator: Early Restoration Device: SLActive dental implant
Immediate restoration or early restoration (4 weeks)
Other Name: SLActive

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782171

Locations
United States, Florida
Private Practice
Boca Raton, Florida, United States, 33431
United States, Indiana
Private Practice
Indianapolis, Indiana, United States, 46280
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Austria
Tiroler Landeskrankenanstaltengesellschaft mbH
Innsbruck, Austria
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, Germany
Ireland
Queens University
Belfast, Ireland
Dublin Dental Hospital
Dublin, Ireland
Netherlands
Rijnland Hospital
Leiderdorp, Netherlands
Portugal
Faculdade de medicina de coimbra
Coimbra, Portugal
Private Practice
Oporto, Portugal
Spain
Private Practice
Barcelona, Spain
Private Practice
Malaga, Spain
Clinica Periobalear
Palma de Mallorca, Spain
Sweden
Private Practice
Falun, Sweden
Switzerland
Private Practice
St. Gallen, Switzerland
Sponsors and Collaborators
Institut Straumann AG
Investigators
Principal Investigator: Axel Zöllner, DDS Private Universität Witten/ Herdecke
  More Information

Publications:
Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00782171     History of Changes
Other Study ID Numbers: CR 06/03
Study First Received: October 28, 2008
Last Updated: June 6, 2012
Health Authority: Austria: Ethikkommission
Germany: Ethics Commission
Ireland: Medical Ethics Research Committee
Netherlands: Independent Ethics Committee
Portugal: Ethics Committee for Clinical Research
Spain: Ethics Committee
Sweden: Institutional Review Board
Switzerland: Ethikkommission
United States: Institutional Review Board

Keywords provided by Institut Straumann AG:
Dental implants

ClinicalTrials.gov processed this record on September 22, 2014