Clinical and immunological outcome of two-piece zirconia-implants - a prospective randomized controlled clinical multicentre trial.
Organizational Data
- DRKS-ID:
- DRKS00013209
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2017-11-21
- Last update in DRKS:
- 2017-11-21
- Registration type:
- Prospective
Acronym/abbreviation of the study
Two-piece zirconia implants
URL of the study
No Entry
Brief summary in lay language
To compare the bone remodelling around ceramik-implants with the bone remodelling of a titanium-gold standard- implant
Brief summary in scientific language
Aim of the study is to compare the mean crestal bone remodeling and the survival and occurence of complications of a novel two-piece zirconia implant with screwed abutment connection to a conventional two-piece standard titanium implant at one, two- and three years after implant placement.
Health condition or problem studied
- Free text:
- Zirconia based dental implant
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Two-piece zirconia implant
- Arm 2:
- Two-piece titanium implant
Endpoints
- Primary outcome:
- Bone resorption after 1, 2 and 3 years in single radiographies
- Secondary outcome:
- The occurence of complications and the concentration of aMMP8 around the implants
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Switzerland
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Graz
- University medical center Basel
- University medical center Zürich
Recruitment period and number of participants
- Planned study start date:
- 2018-01-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 120
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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.
Addresses
Primary Sponsor
- Address:
- Klinik für Zahnärztliche Chirurgie, -Radiologie, Mund- und Kieferheilkunde, Universitäres Zentrum für Zahnmedizin BaselPriv.-Doz. Dr. Sebastian KühlHebelstrasse 34056 BaselSwitzerland
- Telephone:
- 0041 61 2672611
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für Zahnärztliche Chirurgie, -Radiologie, Mund- und Kieferheilkunde, Universitäres Zentrum für Zahnmedizin BaselPriv.-Doz. Dr. Sebastian KühlHebelstrasse 34056 BaselSwitzerland
- Telephone:
- 0041 61 2672611
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Klinik für Zahnärztliche Chirurgie, -Radiologie, Mund- und Kieferheilkunde, Universitäres Zentrum für Zahnmedizin BaselPriv.-Doz. Dr. Sebastian KühlHebelstrasse 34056 BaselSwitzerland
- Telephone:
- 0041 61 2672611
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Klinik für Zahnärztliche Chirurgie, -Radiologie, Mund- und Kieferheilkunde, Universitäres Zentrum für Zahnmedizin BaselPriv.-Doz. Dr. Sebastian KühlHebelstrasse 34056 BaselSwitzerland
- Telephone:
- 0041 61 2672611
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- International Team of Implantology ITIPeter Merian Strasse 884052 BaselSwitzerland
- Telephone:
- +41 (0)61 270 83 83
- Fax:
- Fax +41 (0)61 270 83 84
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission Nordwest- und Zentralschweiz (EKNZ) [Ethikkommission Nordwest- und Zentralschweiz]Hebelstr. 534056 BaselSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://eknz.ch/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- No Entry
- Ethics committee number:
- No Entry
- Vote of the Ethics Committee:
- Pending/not yet approved
- Date of the vote:
- No Entry
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry