Brief description of trial (Data source: BASEC)
Es wird eine prospektive, randomisierte klinische Multicenterstudie an den Universitätskliniken für Zahnmedizin in Basel, Zürich und Graz durchgeführt. Testobjekt ist ein neues, CE zertifiziertes, zweiteiliges Dentalimplantat aus Zirkondioxid (Straumann PURE Ceramic Two Piece Implant 4.1 SP 10, ZLA; Institut Straumann AG, Basel, Schweiz), welches zum Ersatz von Zähnen für Einzelzahnlücken in Ober- und Unterkiefer eingesetzt wird. Als Kontrollgruppe dient ein zweiteiliges Implantat aus Titan (Straumann Tissue Level 4.1 SP 10, SLA; Institut Straumann AG, Basel, Schweiz), welches ein sehr ähnliches makroskopisches- und mikroskopisches Design aufweist und als eines der besten wissenschaftlich dokumentierten Implantate weltweit gilt.
Auf der Basis einer Powerkalkulation wurde eine Implantatzahl von N = 20 pro Gruppe und Studiencenter kalkuliert (insgesamt 60 Testimplantate und 60 Kontrollimplantate), um inklusive zu erwartender Dropouts eine Power von >80% zu erzielen.
Eingeschlossen werden gesunde erwachsene Patienten (> 18 jährig) mit einer- oder mehreren Einzelzahnlücken, die ihre schriftliche Einwilligung an der Studienteilnahme abgegeben haben. Klinisch und röntgenologisch muss ausreichend Knochen vorhanden sein, um ein Implantat mit einem Durchmesser von 4.1mm und mindestens 8mm Länge aufnehmen zu können. Informationen darüber können aus den praeoperativ anzufertigenden Röntgenaufnahmen entnommen werden. Kleinere Augmentationen im Sinne von Kontouraugmentationen stellen hierbei keine Kontraindikation dar und werden mittels Knochenersatzmaterial und BioGide Membran (Geistlich Pharma AG, Wolhusen, Schweiz) nach der wissenschaftlich sehr gut dokumentierten Membrantechnik (sog. Guided Bone Regeneration, GBR) durchgeführt. Ausgeschlossen werden Patienten mit bekannten Parafunktionen, aktiver Parodontitis, > 10 Zigaretten pro Tag, mangelhafter Compliance, sowie generelle Kontraindikationen für eine Therapie mit Implantaten (Immunologische Erkrankungen, chronische Kortik
Health conditions investigated(Data source: BASEC)
N.a.
Health conditions
(Data source: WHO)
Zirconia based dental implant
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Zahnimplantat aus Keramik
Interventions
(Data source: WHO)
Group 1: Two-piece zirconia implant
Group 2: Two-piece titanium implant
Criteria for participation in trial
(Data source: BASEC)
Only patients matching the following criteria will consecutively be included in the investigation:
(i) Patients of 18 years or older who giving their informed, written consent; (ii) single tooth gaps (with at least one adjacent tooth) with a sufficient amount of horizontal and vertical bone (i.e., 50% of the buccal surface needs to be covered with bone) and soft tissue volume for the simultaneous placement of implants with a minimum length of 8 mm and a width of 4.1 mm including need for small transversal bony augmentation in terms of Guided Bone Regeneration (BioGide® membrane)
(iii) acceptance of the scheduled protocol of clinical and radiographic analysis and maintenance.
Exclusion criteria
(Data source: BASEC)
Excluded are all patients with any of the following criteria: (i) heavy smokers (> 10 cigarettes per day); (ii) signs of occlusal parafunctions (e.g. bruxers); (iii) present acute periodontal disease; (iv) lack of compliance or failure to give consent; (v) general contraindications against implant treatment or medication potentially compromising osseointegration (e.g. immunodeficiency, advanced systemic diseases, corticosteroid or bisphosphonate medication); (vi) pregnancy, assessed with a pregnancy test (HCG Schnelltest, DiaChrom bj-Diagnostik, Giessen, Germany); (vii) previous irradiation in the neck/head area.
Excluded are also patients, who meet the following secondary exclusion criterion at or immediately after implant surgery: XIV. Lack of primary stability of the implant (hand testing directly after surgery)
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: None
Minimum age: 18 Years
Inclusion criteria: Only patients matching the following criteria will consecutively be included in the investigation:
(i) Patients of 18 years or older who giving their informed, written consent; (ii) single tooth gaps with a sufficient amount of horizontal and vertical bone and soft tissue volume for the simultaneous placement of implants with a minimum length of 8 mm and a width of 4.1 mm including need for small transversal bony augmentation in terms of Guided Bone Regeneration (BioGide? membrane and BoneCeramic?); (iii) acceptance of the scheduled protocol of clinical and radiographic analysis and maintenance.
Exclusion criteria: Excluded are all patients with any of the following criteria: (i) heavy smokers (> 10 cigarettes per day); (ii) signs of occlusal parafunctions (e.g. bruxers); (iii) present acute periodontal disease; (iv) lack of compliance or failure to give consent; (v) general contraindications against implant treatment or medication potentially compromising osseointegration (e.g. immunodeficiency, advanced systemic diseases, corticosteroid or bisphosphonate medication); (vi) pregnancy, assessed with a pregnancy test (HCG Schnelltest, DiaChrom bj-Diagnostik, Giessen, Germany); (vii) previous irradiation in the neck/head area.
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Further information on trial
Date trial registered
Nov 21, 2017
Incorporation of the first participant
Jan 1, 2018
Recruitment status
Pending
Academic title
(Data source: WHO)
Clinical and immunological outcome of two-piece zirconia-implants - a prospective randomized controlled clinical multicentre trial. - Two-piece zirconia implants
Type of trial
(Data source: WHO)
interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Bone resorption after 1, 2 and 3 years in single radiographies
Secundary end point
(Data source: WHO)
The occurence of complications and the concentration of aMMP8 around the implants
Contact information
(Data source: WHO)
International Team of Implantology ITI
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
No
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, Zurich
Countries
(Data source: WHO)
Austria, Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Universitäres Zentrum für Zahnmedizin (UZB)
0041 61 2672611
sebastian.kuehl@unibas.ch
Contact for general information
(Data source: WHO)
Sebastian
K?hl
Hebelstrasse 3
Klinik f?r Zahn?rztliche Chirurgie, -Radiologie, Mund- und Kieferheilkunde, Universit?res Zentrum f?r Zahnmedizin Basel
0041 61 2672611
sebastian.kuehl@unibas.ch
Contact for scientific information
(Data source: WHO)
Sebastian
K?hl
Hebelstrasse 3
Klinik f?r Zahn?rztliche Chirurgie, -Radiologie, Mund- und Kieferheilkunde, Universit?res Zentrum f?r Zahnmedizin Basel
0041 61 2672611
sebastian.kuehl@unibas.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
16.04.2018
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2017-02298
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