title: A double-blind randomized controlled trial (RCT) of Titanium-13Zirconium versus Titanium Grade IV small-diameter bone level implants in edentulous mandibles--results from a 1-year observation period.
abstract: BACKGROUND
  The use of endosseous dental implants has become common practice for the rehabilitation of edentulous patients, and a two-implant overdenture has been recommended as the standard of care. The use of small-diameter implants may extend treatment options and reduce the necessity for bone augmentation. However, the mechanical strength of titanium is limited, so titanium alloys with greater tensile and fatigue strength may be preferable.
  
  
  OBJECTIVE
  This randomized, controlled, double-blind, multicenter study investigated in a split-mouth model whether small-diameter implants made from Titanium-13Zirconium alloy (TiZr, Roxolid™) perform at least as well as Titanium Grade IV implants.
  
  
  METHODS
  Patients with an edentulous mandible received one TiZr and one Ti Grade IV small-diameter bone level implant (3.3 mm, SLActive®) in the interforaminal region. The site distribution was randomized and double-blinded. Outcome measures included change in radiological peri-implant bone level from surgery to 12 months post-insertion (primary), implant survival, success, soft tissue conditions, and safety (secondary).
  
  
  RESULTS
  Of 91 treated patients, 87 were available for the 12-month follow-up. Peri-implant bone level change (-0.3 ± 0.5 mm vs -0.3 ± 0.6 mm), plaque, and sulcus bleeding indices were not significantly different between TiZr and Ti Grade IV implants. Implant survival rates were 98.9 percent and 97.8 percent, success rates were 96.6 percent and 94.4 percent, respectively. Nineteen minor and no serious adverse events were related to the study devices.
  
  
  CONCLUSIONS
  This study confirms that TiZr small-diameter bone level implants provide at least the same outcomes after 12 months as Ti Grade IV bone level implants. The improved mechanical properties of TiZr implants may extend implant therapy to more challenging clinical situations.
authors.affiliation: Johannes-Gutenberg University, Mainz, Germany. al-nawas@mkg.klinik.unimainz.de
authors.forename: Bilal
authors.initials: B
authors.lastname: Al-Nawas
authors.forename: Urs
authors.initials: U
authors.lastname: Brägger
authors.forename: Henny J A
authors.initials: HJ
authors.lastname: Meijer
authors.forename: Ignace
authors.initials: I
authors.lastname: Naert
authors.forename: Rigmor
authors.initials: R
authors.lastname: Persson
authors.forename: Alessandro
authors.initials: A
authors.lastname: Perucchi
authors.forename: Marc
authors.initials: M
authors.lastname: Quirynen
authors.forename: Gerry M
authors.initials: GM
authors.lastname: Raghoebar
authors.forename: Torsten E
authors.initials: TE
authors.lastname: Reichert
authors.forename: Eugenio
authors.initials: E
authors.lastname: Romeo
authors.forename: Hendrik J
authors.initials: HJ
authors.lastname: Santing
authors.forename: Martin
authors.initials: M
authors.lastname: Schimmel
authors.forename: Stefano
authors.initials: S
authors.lastname: Storelli
authors.forename: Christiaan
authors.initials: C
authors.lastname: ten Bruggenkate
authors.forename: Betty
authors.initials: B
authors.lastname: Vandekerckhove
authors.forename: Wilfried
authors.initials: W
authors.lastname: Wagner
authors.forename: Daniel
authors.initials: D
authors.lastname: Wismeijer
authors.forename: Frauke
authors.initials: F
authors.lastname: Müller
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D003758:Dental Implantation, Endosseous / Q000379:methods; D015921:Dental Implants; D017267:Dental Prosthesis Design; D004311:Double-Blind Method; D007575:Jaw, Edentulous / Q000534:rehabilitation; D008334:Mandible; D014025:Titanium; D016896:Treatment Outcome; D015040:Zirconium
chemical_list: D015921:Dental Implants; D014025:Titanium; D015040:Zirconium