Evidence map›Paper›PMID 26458813›Full record

Trial reportBMC oral health2015

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

Frauke Müller, Bilal Al-Nawas, Stefano Storelli, Marc Quirynen, Stefan Hicklin, Jose Castro-Laza, Renzo Bassetti, Martin Schimmel, Roxolid Study Group

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC oral health, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01878331 (Long-term, Prospective, Cohort Study to Evaluate Safety and Efficacy of Two Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants for Removable Prosthesis in Patients With Edentulous Mandibles), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
7.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01878331 completednot on this map

Long-term, Prospective, Cohort Study to Evaluate Safety and Efficacy of Two Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants for Removable Prosthesis in Patients With Edentulous Mandibles

TypeobservationalSponsorInstitut Straumann AGRan2013 to 2018Enrolled49ConditionsJaw, Edentulous
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 74 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 5 countries.

Frauke MüllerDivision of Gerodontology and Removable Prosthodontics, University of Geneva, Geneva, Switzerland. frauke.mueller@unige.ch.
Bilal Al-NawasJohannes-Gutenberg University Mainz, Mainz, Germany. al-nawas@mkg.klinik.uni-mainz.de.
Stefano StorelliUniversity of Milan, Dental Clinic, San Paolo Hospital, Milan, Italy. stefano.storelli@studioplinio.it.
Marc QuirynenSchool of Dentistry, Catholic University Leuven, Leuven, Belgium. marc.quirynen@uz.kuleuven.ac.be.
Stefan HicklinUniversity of Bern, School of Dental Medicine, Bern, Switzerland. stefan.hicklin@zmk.unibe.ch.
Jose Castro-LazaUniversity of Regensburg Clinic, Regensburg, Germany. Jose.Castro-Laza@klinik.uni-regensburg.de.
Renzo BassettiCantonal Hospital Lucerne, Clinic for Oral and Maxillofacial Surgery, Lucerne, Switzerland. renzo.bassetti@luks.ch.
Martin SchimmelDivision of Gerodontology and Removable Prosthodontics, University of Geneva, Geneva, Switzerland. martin.schimmel@zmk.unibe.ch.
Roxolid Study Group
University of Geneva · CHUniversity of Bern · CHOspedale San Paolo · ITUniversity of Lucerne · CHUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsThe 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.

resultsOf 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.

conclusionsAfter 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 registrationRegistered on www.clinicaltrials.gov: NCT01878331.

Indexed as

Dental Implantation, EndosseousDental ImplantsDental Prosthesis DesignJaw, EdentulousAlloysDenture, OverlayDouble-Blind MethodFollow-Up StudiesHumansMandibleTitaniumZirconiumAlloysDental ImplantsTitaniumZirconium

Identifiers

PMID26458813
PMCPMC4603635
OpenAlexW2110829987

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.