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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00012927 |
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Date of registration:
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07/09/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Template-guided implantation of one-piece ceramic implants.
A prospective clinical pilot study.
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Scientific title:
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Template-guided implantation of one-piece ceramic implants.
A prospective clinical pilot study.
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Date of first enrolment:
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18/09/2017 |
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Target sample size:
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12 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00012927 |
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Study type:
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interventional |
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Study design:
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Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Sigmar
Schnutenhaus |
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Address:
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Breiter Wasmen 10
78247
Hilzingen
Germany |
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Telephone:
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07731 182755 |
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Email:
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sigmar.schnutenhaus@uniklinik-ulm.de |
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Affiliation:
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Private Praxis und Universitätsklinikum Ulm, Klinik für Zahnärztliche Prothetik |
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Name:
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Sigmar
Schnutenhaus |
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Address:
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Breiter Wasmen 10
78247
Hilzingen
Germany |
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Telephone:
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07731 182755 |
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Email:
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sigmar.schnutenhaus@uniklinik-ulm.de |
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Affiliation:
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Private Praxis und Universitätsklinikum Ulm, Klinik für Zahnärztliche Prothetik |
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Key inclusion & exclusion criteria
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Inclusion criteria: Gaps in the upper and / or lower jaw tooth area
Free-ending situations in the upper and / or lower jaw area
The extraction is at least 3 months. Only early implantations (3 - 6 months post-extraction) and late implantation (> 6 months post-extraction) are performed.
The template must be applied to the tooth. For this purpose, more than 5 residual teeth must be present in the jaw to be implanted.
The patient has good oral hygiene and compliance.
A preimplantological hygiene phase must be completed.
Patient's consent.
Exclusion criteria: Persons under 18 or not legally competent persons
Untreated acute periodontitis with pocket depths> 4 mm.
Strong smokers (more than 10 zig / d)
Taking bisphosphonates
Pregnant
Alcohol or drug addicts
Patients with an infectious disease such as hepatitis or HIV or AIDS
Patients with severe diabetes m.
immediate implantation
Width of the gap in the mesio-distal direction with single tooth gaps> 7.1 mm.
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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K08.1
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Loss of teeth due to accident, extraction or local periodontal disease
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K08.1
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Intervention(s)
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Group 1: Template-guided implantation of one-piece full-ceramic implants with a new, sleeveless drilling template.
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Primary Outcome(s)
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Deviation of the planned implant position from the actual position. The deviation is described by the distance at the crestal implant penetration point, at the apical end of the implant, at the height of the implant and in the axis deviation. The measurement will be performed immediately after insertion of the implant.
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Secondary Outcome(s)
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Indication limitations for the stencil design of 2ingis.
Clinical complications: Insufficient template content, eg.
Technical complication: stencil fracture or the like.
Feasibility study for a subsequent multicentric field study.
The feasibility study should give evidence of a sufficient clinical accuracy of the used templates and work out possible indication restrictions.
All recordings are made on the day of Implantation. No further follow-up is performed.
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Source(s) of Monetary Support
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VITA Zahnfabrik H, Rauter GmbH & Co KGvitaclinical
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Ethics review
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Status: Approved
Approval date: 24/08/2017
Contact:
ethik-kommission@uni-ulm.de
Ethikkommission der Universität Ulm
+49-731-50022050
ethik-kommission@uni-ulm.de
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