A Study to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Diameter Bone Level Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00905840
First received: May 20, 2009
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

The primary study objective is to compare the change of crestal bone level at the test implant compared the Titanium (grade IV) implant between surgery and 12 month post surgery.


Condition Intervention
Jaw, Edentulous
Device: Titanium implants
Device: TiZr implants

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double Blind, Clinical Trial to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Diameter Bone Level Implants Which Will be Restored With a Removable Prosthesis by Comparing Two Different Implant Alloys in Split Mouth Design

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • Change in Crestal Bone Level between surgery and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Success and survival rate of the study implants [ Time Frame: at 6,12, 24 and 36 months post loading ] [ Designated as safety issue: Yes ]

Enrollment: 91
Study Start Date: November 2007
Study Completion Date: September 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: control
split-mouth
Device: Titanium implants
A Straumann 3.3mm diameter titanium Bone Level implant will be placed during surgery.
Active Comparator: Test
split-mouth
Device: TiZr implants
A Straumann 3.3mm diameter TiZr Bone Level implant will be placed during surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have voluntarily signed the informed consent form
  • Males and females must be 18 years of age.
  • Patients must present with an edentulous mandible at the time of surgery.
  • The last tooth or teeth in the mandible must have been extracted or lost more than 8 weeks before the date of first stage surgery.
  • The opposing dentition must be edentulous with a denture (implant borne or conventional) or natural or restored teeth
  • Adequate bone height of at least 9 mm above vital structures (because the minimal available implant lengths is 8mm) in the intraforaminal region. Available bone width should be in such way that 3.3 mm implants can be placed without the use of concurrent bone augmentation techniques. Harvested bone from the drilling sites may be used to cover minor dehiscence defects.
  • Patients must be committed to participate in the study for three years of follow-up examinations

Exclusion Criteria:

  • Medical conditions requiring prolonged use of steroids
  • History of leukocyte dysfunction and deficiencies
  • Patients with sever hemophilia
  • History of head and neck radiation or chemotherapy
  • Patients with history of renal failure
  • The application of bisphosphonate medication
  • History of 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 with known infection of HIV
  • Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco (not greater than 10 cigarette equivalents)
  • Fertile females with no adequate method of birth control (contraceptive pill, barrier method, etc.)
  • 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, unreliability.
  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: NCT00905840

Locations
Belgium
Catholic University Leuven School of Dentistry
Leuven, Belgium, 3000
Germany
J. Gutenberg University, Oral and Maxillofacial Surgery
Mainz, Germany, 55131
Klinikum der Universität Regensburg
Regensburg, Germany, 93053
Italy
Universitá degli Studi di Milano
Milano, Italy, 20142
Netherlands
Academic Center for Dentistry Amsterdam (ACTA)
Amsterdam, Netherlands, 1066 EA
University Medical Center Groningen- UMCG
Groningen, Netherlands
Switzerland
Université de Genève- Section médicine dentaire
Geneve, Switzerland, 1211
Kantonsspital Luzern
Luzern, Switzerland, 6000
Sponsors and Collaborators
Institut Straumann AG
Investigators
Principal Investigator: Bilal Al-Nawas, PD Dr. J. Gutenberg University
  More Information

No publications provided

Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00905840     History of Changes
Other Study ID Numbers: CR 04/07
Study First Received: May 20, 2009
Last Updated: July 9, 2013
Health Authority: Germany: Ethics Commission
Italy: Ethics Committee
Belgium: Institutional Review Board
Netherlands: Independent Ethics Committee
Switzerland: Ethikkommission

Additional relevant MeSH terms:
Jaw, Edentulous
Mouth, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on July 28, 2014