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Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: five-year results from a double-blind, randomized controlled trial.

ABSTRACT: BACKGROUND:The aim of this study was to compare the 5-year survival and success rates of 3.3 mm dental implants either made from titanium-zirconium (TiZr) alloy or from Grade IV titanium (Ti Grade IV) in mandibular implant-based removable overdentures. METHODS:The core study had a follow-up period of 36 months and was designed as a randomized, controlled, double-blind, split-mouth multicenter clinical trial. Patients with edentulous mandibles received two Straumann Bone Level implants (diameter 3.3 mm, SLActive®), one of TiZr (test) and one of Ti Grade IV (control), in the interforaminal region. This follow-up study recruited patients from the core study and evaluated the plaque and sulcus bleeding indices, radiographic crestal bone level, as well as implant survival and success 60 months after implant placement. RESULTS:Of the 91 patients who initially received implants, 75 completed the 36 month follow-up and 49 were available for the 60 month examination. Two patients were excluded so that a total of 47 patients with an average age of 72?±?8 years were analysed. The characteristics and 36-month performance of the present study cohort did not differ from the non-included initial participants (p?>?0.05). In the period since the 36-month follow-up examination, no implant was lost. The cumulative implant survival rate was 98.9 % for the TiZr group and 97.8 % for the Ti Grade IV group. Crestal bone level changes at 60 months were not different in the test and control group (TiZr -0.60?±?0.69 mm and Ti Grade IV -0.61?±?0.83 mm; p?=?0.96). The cumulative implant success rate after 60 months was 95.8 and 92.6 % for TiZr and Ti Grade IV, respectively. CONCLUSIONS:After 60 months, the positive outcomes of the 36 month results for TiZr and Ti Grade IV implants were confirmed, with no significant differences with regard to crestal bone level change, clinical parameters and survival or success rates. TiZr implants performed equally well compared to conventional Ti Grade IV 3.3 mm diameter-reduced implants for mandibular removable overdentures. TRIAL REGISTRATION:Registered on www.clinicaltrials.gov: NCT01878331.

SUBMITTER: Muller F

PROVIDER: S-EPMC4603635 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: five-year results from a double-blind, randomized controlled trial.

Müller Frauke F Al-Nawas Bilal B Storelli Stefano S Quirynen Marc M Hicklin Stefan S Castro-Laza Jose J Bassetti Renzo R Schimmel Martin M

BMC oral health 20151012 1

<h4>Background</h4>The aim of this study was to compare the 5-year survival and success rates of 3.3 mm dental implants either made from titanium-zirconium (TiZr) alloy or from Grade IV titanium (Ti Grade IV) in mandibular implant-based removable overdentures.<h4>Methods</h4>The core study had a follow-up period of 36 months and was designed as a randomized, controlled, double-blind, split-mouth multicenter clinical trial. Patients with edentulous mandibles received two Straumann Bone Level impl ...[more]

PMID: 26458813

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Project description:BACKGROUND:Traditionally, dental implants have been made from titanium or titanium alloys. Alternatively, zirconia-based ceramic implants have been developed with similar characteristics of functional strength and osseointegration. Ceramic implants offer advantages in certain settings, e.g. in patients who object to metal dental implants. The aim of this study was to investigate the mid-term (36 months) clinical performance of a ceramic monotype implant in single-tooth edentulous area. METHODS:This was a prospective, open-label, single-arm study in patients requiring implant rehabilitation in single-tooth edentulous area. Ceramic implants (PURE Ceramic Implant, Institut Straumann AG, Basel, Switzerland) with a diameter of 4.1 mm were placed following standard procedure and loaded with provisional and final prostheses after 3 and 6 months, respectively. Implant survival rate and implant success rate were evaluated and crestal bone levels were measured by analysing standardized radiographs during implant surgery and at 6, 12, 24 and 36 months. RESULTS:Forty-four patients received a study implant, of whom one patient withdrew consent after 3 months. With one implant lost during the first 6 months after surgery, the implant survival rate was 97.7% at 6 months. No further implants were lost over the following 30 months, and 3 patients were lost to follow-up during this time frame. This led to a survival rate of 97.5% at 36 months. Six months after implant surgery 93.0% of the implants were considered "successful", increasing to 97.6% at 12 months and remaining at this level at 24 months (95.1%) and 36 months (97.5%). Bone loss was most pronounced in the first half-year after implant surgery (0.88?±?0.86 mm). By contrast, between 12 and 36 months the mean bone level remained stable (minimal gain of 0.06 [± 0.60] mm). Hence, the overall bone loss from implant surgery to 36 months was 0.97 (± 0.88) mm. CONCLUSIONS:In the follow-up period ceramic implants can achieve favourable clinical outcomes on a par with titanium implants. For instance, these implants can be recommended for patients who object to metal dental implants. However, longer term studies with different edentulous morphology need to confirm the present data. TRIAL REGISTRATION:Registered on www.clinicaltrials.gov : NCT02163395 .

Dataset Information

Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: five-year results from a double-blind, randomized controlled trial.

Publications

Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: five-year results from a double-blind, randomized controlled trial.

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