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N/A N=91 Randomized Quadruple-blind Treatment

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

Jaw, Edentulous

Enrolled (actual)
91
Serious AEs
15.4%
Results posted
Nov 2014
Primary outcome: Primary: Change in Crestal Bone Level Between Surgery and 12 Months, to Compare Between the Titan Zircon Implant and the Titan Grade IV Implant. — 0.3; 0.1 mm — p=0.025

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Titanium Zircon implant (Device); Titanium Grade IV implant (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Institut Straumann AG
Primary completion
Sep 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Crestal Bone Level Between Surgery and 12 Months, to Compare Between the Titan Zircon Implant and the Titan Grade IV Implant.
0.3; 0.1 0.025 sig
SECONDARY
Success and Survival Rate of Both Study Implants Titanium Grade IV and Titanium Zirconium) According to Definition by Buser et al. 1990
84; 86; 79; 80; 73; 74 0.1573
SECONDARY
Soft Tissue and Safety Assessments
20; 19; 10; 9; 16; 18 0.3617

Summary

The purpose of this study is to assess the change of crestal bone level at the Titanium Zirconium (TiZr) compared to Titanium (grade IV) implant between surgery and 6, 12, 24, and 36 month post surgery.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00905840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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