Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: five-year results from a double-blind, randomized controlled trial
Identifieur interne : 000D10 ( Main/Exploration ); précédent : 000D09; suivant : 000D11Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: five-year results from a double-blind, randomized controlled trial
Auteurs : Frauke Müller [Suisse] ; Bilal Al-Nawas [Allemagne] ; Stefano Storelli [Italie] ; Marc Quirynen [Belgique] ; Stefan Hicklin [Suisse] ; Jose Castro-Laza [Allemagne] ; Renzo Bassetti [Suisse] ; Martin Schimmel [Suisse]Source :
- BMC Oral Health [ 1472-6831 ] ; 2015.
Abstract
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.
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.
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 (
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.
Registered on www.clinicaltrials.gov:
Url:
DOI: 10.1186/s12903-015-0107-6
PubMed: 26458813
PubMed Central: 4603635
Affiliations:
- Allemagne, Belgique, Italie, Suisse
- Canton de Berne, Canton de Genève, Lombardie, Rhénanie-Palatinat
- Berne, Genève, Mayence, Milan
- Université de Berne, Université de Genève
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Le document en format XML
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>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.</p>
</sec>
<sec><title>Methods</title>
<p>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.</p>
</sec>
<sec><title>Results</title>
<p>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 (<italic>p</italic>
> 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; <italic>p</italic>
= 0.96). The cumulative implant success rate after 60 months was 95.8 and 92.6 % for TiZr and Ti Grade IV, respectively.</p>
</sec>
<sec><title>Conclusions</title>
<p>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.</p>
</sec>
<sec><title>Trial registration</title>
<p>Registered on www.clinicaltrials.gov: <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01878331">NCT01878331</ext-link>
</p>
</sec>
</div>
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<affiliations><list><country><li>Allemagne</li>
<li>Belgique</li>
<li>Italie</li>
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<li>Canton de Genève</li>
<li>Lombardie</li>
<li>Rhénanie-Palatinat</li>
</region>
<settlement><li>Berne</li>
<li>Genève</li>
<li>Mayence</li>
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</settlement>
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<name sortKey="Schimmel, Martin" sort="Schimmel, Martin" uniqKey="Schimmel M" first="Martin" last="Schimmel">Martin Schimmel</name>
<name sortKey="Schimmel, Martin" sort="Schimmel, Martin" uniqKey="Schimmel M" first="Martin" last="Schimmel">Martin Schimmel</name>
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<country name="Italie"><region name="Lombardie"><name sortKey="Storelli, Stefano" sort="Storelli, Stefano" uniqKey="Storelli S" first="Stefano" last="Storelli">Stefano Storelli</name>
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<country name="Belgique"><noRegion><name sortKey="Quirynen, Marc" sort="Quirynen, Marc" uniqKey="Quirynen M" first="Marc" last="Quirynen">Marc Quirynen</name>
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