Clinical and immunological outcome of two-piece zirconia-implants - a prospective randomized controlled clinical multicentre trial.

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00013209
• Date of registration: 21/11/2017
• Prospective Registration: Yes
• Primary sponsor: Klinik für Zahnärztliche Chirurgie, -Radiologie, Mund- und Kieferheilkunde, Universitäres Zentrum für Zahnmedizin Basel
• Public title: Clinical and immunological outcome of two-piece zirconia-implants - a prospective randomized controlled clinical multicentre trial.
• Scientific title: Clinical and immunological outcome of two-piece zirconia-implants - a prospective randomized controlled clinical multicentre trial. - Two-piece zirconia implants
• Date of first enrolment: 01/01/2018
• Target sample size: 120
• Recruitment status: Pending
• URL: http://drks.de/search/en/trial/DRKS00013209
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Austria, Switzerland

Contacts

• Name: Sebastian Kühl
• Affiliation: Klinik für Zahnärztliche Chirurgie, -Radiologie, Mund- und Kieferheilkunde, Universitäres Zentrum für Zahnmedizin Basel

• Name: Sebastian Kühl
• Affiliation: Klinik für Zahnärztliche Chirurgie, -Radiologie, Mund- und Kieferheilkunde, Universitäres Zentrum für Zahnmedizin Basel

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Zirconia based dental implant

Intervention(s)

Group 1: Two-piece zirconia implant
Group 2: Two-piece titanium implant

Primary Outcome(s)

Bone resorption after 1, 2 and 3 years in single radiographies

Secondary Outcome(s)

The occurence of complications and the concentration of aMMP8 around the implants

Source(s) of Monetary Support

International Team of Implantology ITI

Ethics review

Status: Pending/not yet approved
Approval date:
Contact:

Ethikkommission Nordwest- und Zentralschweiz (EKNZ) [Ethikkommission Nordwest- und Zentralschweiz]

Results

• URL: http://drks.de/search/en/trial/DRKS00013209#studyResults