Brief description of trial (Data source: BASEC)
Für die Studie werden Patienten gesucht, bei denen eine Einzelzahnlücke durch ein Keramikimplantat geschlossen werden soll. Dieses Implantat wird nach der Einheilzeit mit einer Krone versorgt. Im Rahmen dieser Studie werden drei verschiedene Kronenmaterialien verwendet. Welches dieser Kronenmaterialien jeweils verwendet wird, wird mittels Zufallsentscheid bestimmt (=randomisiert). Sowohl das Implantat als auch die drei Kronenmaterialien werden seit Jahren in der Zahnmedizin eingesetzt.
Health conditions investigated(Data source: BASEC)
Einzelzahnlücke, die durch ein Keramikimplantat geschlossen werden soll
Health conditions
(Data source: WHO)
K08.1;Loss of teeth due to accident, extraction or local periodontal disease;K08.1
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Einzelner fehlender Zahn im Seiten- oder Backenzahnbereich (Ober- oder Unterkiefer)
Interventions
(Data source: WHO)
Group 1: Zirconia implants (ceramic.implant, VITA).
Prosthetic reconstruction: monolithic zirconia (VITA YZ)
Group 2: Zirconia implants (ceramic.implant, VITA).
Prosthetic reconstruction: monolithic polymer infiltrated ceramic (VITA Enamic)
Group 3: Zirconia implants (ceramic.implant, VITA).
Prosthetic reconstruction: monolithic polymer (VITA CAD-Temp)
Criteria for participation in trial
(Data source: BASEC)
Einzelner fehlender Zahn im Seiten- oder Backenzahnbereich (Ober- oder Unterkiefer)
Exclusion criteria
(Data source: BASEC)
Rauchen von mehr als 15 Zigaretten pro Tag
Schlechte Mundhygiene
Aktive parodontale Erkrankung
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: None
Minimum age: 20 Years
Inclusion criteria: ?Male and female patients at least 20 years old, in need of an implant supported single tooth restoration
?No general medical condition which represents a contraindication to implant treatment
?One missing tooth in the mandible or maxilla in position of premolars or molars
?At least 10 mm of vertical bone height in the mandible allowing for the placement of a 8 mm implant (2 mm safety distance to inferior alveolar nerve)
?At least 7 mm of vertical bone height in the maxilla allowing for a 1 mm internal sinus elevation procedure (Osteotome technique).
?Signed informed consent form
Exclusion criteria: ?Smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers)
?Poor oral hygiene after hygienic phase (Plaque Index over 30%)
?Active periodontal disease
?Women who are pregnant or breast feeding at the date of inclusion
?Known or suspected non-compliance, drug or alcohol abuse
?Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
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Further information on trial
Date trial registered
Nov 15, 2016
Incorporation of the first participant
Nov 22, 2016
Recruitment status
Complete
Academic title
(Data source: WHO)
A 5-year clinical study on the performance of 8 mm zirconia one-piece implants restored with three restoration materials differing in the elastic modulus - ZrO2 8 mm
Type of trial
(Data source: WHO)
interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Mean marginal bone level after 5
years, measured by standardized digital periapical radiographs.
Secundary end point
(Data source: WHO)
Implant survival and biological complications (mucositis, periimplantits) as well as survival rate and technical complications of the three reconstruction materials, assessed after 1, 3 and 5 years
Contact information
(Data source: WHO)
VITA Zahnfabrik
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)
Zurich
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Ronald Jung
+41 44 634 04 04
research.rzm@zzm.uzh.ch
Contact for general information
(Data source: WHO)
Ronald
Jung
Plattenstrasse 11
Zentrum f?r Zahnmedizin, Klinik f?r Rekonstruktive Zahnmedizin, Universit?t Z?rich
+41 44 634 04 04
ronald.jung@zzm.uzh.ch
Contact for scientific information
(Data source: WHO)
Ronald
Jung
Plattenstrasse 11
Zentrum f?r Zahnmedizin, Klinik f?r Rekonstruktive Zahnmedizin, Universit?t Z?rich
+41 44 634 04 04
ronald.jung@zzm.uzh.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
28.09.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-00955
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