Trial document

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DRKS-ID: DRKS00000240

Trial Description

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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

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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.

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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.

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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

DRKS-ID: DRKS00000240
Date of Registration in DRKS: 2009/10/27
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 261/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

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Secondary IDs

Universal Trial Number (UTN): U1111-1112-1784

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Health Condition or Problem studied

Free text: fracture of the restoration, secondary caries
ICD10: K02.9 - Dental caries, unspecified

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Interventions/Observational Groups

Arm 1: Long-term performance (probe mirror photos) according to USPHS criteria of crown placement of molar teeth in the controlgroup IPS e.max CAD
Arm 2: Long-term performance (probe mirror photos) according to USPHS criteria of crown placement of molar teeth in the controlgroup IPS e.max CAD

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Active control
Purpose: Treatment
Assignment: Parallel
Phase: N/A
Off-label Drug use: [---]*

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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)

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Secondary Outcome

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

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Recruitment

Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2009/11/15
Target Sample Size: 40
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 70 Years

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Additional Inclusion Criteria

Two comparable, teeth (molars) in need of a crown restoration, good oral hygiene, healthy periodontal condition, healthy endodontical condition

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Exclusion Criteria

Teeth are not in need of a crown restoration

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Addresses

Primary Sponsor
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- Ivoclar Vivadent AG
- Bendererstrasse 2
- 9494 Schaan / Liechtenstein
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- Telephone: 004232353261
- Fax: 004232354261
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Universitätsklinikum Freiburg Klinik für Zahn-, Mund- und Kieferheilkunde Abteilung für Zahnärztliche Prothetik
- Ms. Dr. Petra Güß
- Hugstetterstr.55
- 79104 Freiburg
- Germany
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- Telephone: 0761 270 4843
- Fax: 0761 270 4824
- E-mail: petra.guess at uniklinik-freiburg.de
- URL: http://www.uniklinik-freiburg.de/prothetik/live/index.html
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Contact for Public Queries
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- Universitätsklinikum Freiburg Klinik für Zahn-, Mund- und Kieferheilkunde Abteilung für Zahnärztliche Prothetik
- Ms. Dr. Petra Güß
- Hugstetterstr.55
- 79104 Freiburg
- Germany
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- Telephone: 0761 270 4843
- Fax: 0761 270 4824
- E-mail: petra.guess at uniklinik-freiburg.de
- URL: http://www.uniklinik-freiburg.de/prothetik/live/index.html
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Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- Ivoclar Vivadent AG
- Bendererstrasse 2
- 9494 Schaan / Lichtenstein
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- Telephone: 004232353261
- Fax: 004232354261
- E-mail: thomas.voelkel at ivoclarvivadent.com
- URL: http://www.ivoclarvivadent.com
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Status

Recruitment Status: Recruiting planned
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.