Trial document
DRKS00000240
Trial Description
Title
Long-term performance and survival rate of press veneered zirconia and monolithic CAD/CAM lithium disilicate crowns: A prospective randomized clinical splitmouth study over 5 years
Trial Acronym
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URL of the Trial
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Brief Summary in Lay Language
The aim of present clinical study is to evaluate the long-term performance of posterior crowns using two different all-ceramic systems (IPS e.max ZirCAD/ ZirPress SC und IPS e.max CAD Ivoclar- Vivadent, Schaan, Lichtenstein). Each patient will receive two crown restorations, with comparable position of the restorations. Recall evaluation is perfomed over a 5 year period after insertion of the restorations. During the observation period after 1 year, 2, 3 and 5 years restorations are investigated and rated according to standardized clinical parameters.
Brief Summary in Scientific Language
Prosthodonitc restaurations are used to imitate natural teeth in functionand esthetics.The aim of this randomised controlled clinical study is to evaluate the long-term performance of posterior crowns using two different all-ceramic systems (IPS e.max ZirCAD/ ZirPress SC und IPS e.max CAD Ivoclar- Vivadent, Schaan, Lichtenstein). Recall evaluation is perfomed over a 5 year period after insertion of the restorations. A splitmouth design, with comparable position of the restorations is applied in the present clinical study. One of the restorations will be frabricated using IPS e.max ZirCAD/ ZirPress SC ceramics, the other one from IPS e.max CAD. During the observation period (Baseline (2 weeks after insertion), after 1 year, 2, 3 and 5 years all restorations are investigated and rated according to the United States Public Health Service (USPHS) criteria.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00000240
- 2009/10/27
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- no
- Approved
- 261/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
- U1111-1112-1784
Health Condition or Problem studied
- fracture of the restoration, secondary caries
- K02.9 - Dental caries, unspecified
Interventions/Observational Groups
- Long-term performance (probe mirror photos) according to USPHS criteria of crown placement of molar teeth in the controlgroup IPS e.max CAD
- Long-term performance (probe mirror photos) according to USPHS criteria of crown placement of molar teeth in the controlgroup IPS e.max CAD
Characteristics
- Interventional
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- Randomized controlled trial
- Open (masking not used)
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- Active control
- Treatment
- Parallel
- N/A
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Primary Outcome
primary: Survival time of all-ceramic crowns using two all-ceramic systems (taking ointo account technical, biological failures, necessitating a renewal of the restauration)
Secondary Outcome
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Countries of Recruitment
- Germany
Locations of Recruitment
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Recruitment
- Planned
- 2009/11/15
- 40
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 70 Years
Additional Inclusion Criteria
Two comparable, teeth (molars) in need of a crown restoration, good oral hygiene, healthy periodontal condition, healthy endodontical condition
Exclusion Criteria
Teeth are not in need of a crown restoration
Addresses
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start of 1:1-Block address primary-sponsor
- Ivoclar Vivadent AG
- Bendererstrasse 2
- 9494 Schaan / Liechtenstein
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 004232353261
- 004232354261
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end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätsklinikum Freiburg Klinik für Zahn-, Mund- und Kieferheilkunde Abteilung für Zahnärztliche Prothetik
- Ms. Dr. Petra Güß
- Hugstetterstr.55
- 79104 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0761 270 4843
- 0761 270 4824
- petra.guess at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de/prothetik/live/index.html
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsklinikum Freiburg Klinik für Zahn-, Mund- und Kieferheilkunde Abteilung für Zahnärztliche Prothetik
- Ms. Dr. Petra Güß
- Hugstetterstr.55
- 79104 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0761 270 4843
- 0761 270 4824
- petra.guess at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de/prothetik/live/index.html
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Ivoclar Vivadent AG
- Bendererstrasse 2
- 9494 Schaan / Lichtenstein
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 004232353261
- 004232354261
- thomas.voelkel at ivoclarvivadent.com
- http://www.ivoclarvivadent.com
end of 1:1-Block address contact materialSupport
Status
- Recruiting planned
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Trial Publications, Results and other Documents
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