Template-guided implantation of one-piece ceramic implants. A prospective clinical pilot study.
Organizational Data
- DRKS-ID:
- DRKS00012927
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2017-09-07
- Last update in DRKS:
- 2024-01-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The aim of the study is to investigate the implant-guided implantation of one-piece full-ceramic implants with a new, sleeveless drilling template. Due to the guided implant bed preparation and insertion of the implants an optimal implant position is to be achieved with regard to the planned prosthetic supply and the optimal use of the existing bone offer. The drill template to be examined here does not use metal sleeves to guide the drills, but guides the head of the surgical elbow via external attachments. The bores can thus be made contactless, without contact with a titanium guide sleeve.
Brief summary in scientific language
In this pilot study, the accuracy of the implant placement is to be determined in relation to the previously virtually planned position. In addition, the feasibility and the indicative limits for the drilling template used here should be described. The null hypothesis is that there is no difference in accuracy to conventional drilling templates with guide sleeves. It is a monocentric prospective controlled clinical trial. 12 patients who require the implant-prosthetic restoration of a gap or / and a free-end situation in the upper or lower jaw participate in the study. Primary target size is the degree of correspondence between clinical implant position and planning. As a secondary target, technical complications are investigated during implant bed preparation.
Health condition or problem studied
- ICD10:
- K08.1 - Loss of teeth due to accident, extraction or local periodontal disease
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Template-guided implantation of one-piece full-ceramic implants with a new, sleeveless drilling template.
Endpoints
- Primary outcome:
- 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.
- Secondary outcome:
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Doctor's practice Hilzingen
Recruitment period and number of participants
- Planned study start date:
- 2017-09-18
- Actual study start date:
- 2017-09-18
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2017-12-18
- Target Sample Size:
- 12
- Final Sample Size:
- 12
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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.
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Ulm/Studienleiter: Prof. Dr. Ralph G. Luthardt, Klinik für Zahnärztliche ProthetikAlbert-Einstein-Allee 1189081 UlmGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-ulm.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Private Praxis und Universitätsklinikum Ulm, Klinik für Zahnärztliche ProthetikProf. Dr. Sigmar SchnutenhausBreiter Wasmen 1078247 HilzingenGermany
- Telephone:
- 07731 182755
- Fax:
- 07731 182766
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-ulm.de/zmk2
Contact for Public Queries
- Address:
- Private Praxis und Universitätsklinikum Ulm, Klinik für Zahnärztliche ProthetikProf. Dr. Sigmar SchnutenhausBreiter Wasmen 1078247 HilzingenGermany
- Telephone:
- 07731 182755
- Fax:
- 07731 182766
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-ulm.de/zmk2
Principal Investigator
- Address:
- Private Praxis und Universitätsklinikum Ulm, Klinik für Zahnärztliche ProthetikProf. Dr. Sigmar SchnutenhausBreiter Wasmen 1078247 HilzingenGermany
- Telephone:
- 07731 182755
- Fax:
- 07731 182766
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-ulm.de/zmk2
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- VITA Zahnfabrik H, Rauter GmbH & Co KGvitaclinicalBallyweg 679713 Bad SäckingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universität UlmHelmholtzstr. 2089081 UlmGermany
- Telephone:
- +49-731-50022050
- Fax:
- +49-731-50022036
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-07-20
- Ethics committee number:
- 268/17
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-08-24
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
- 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:
- Precision of sleevless 3D drill guides for insertion of one-piece ceramic implants: a prospective clinical trial. S. Schnutenhaus, V. von Koenigsmarck, S. Blender, L. Ambrosius, R.G. Luthardt, H. Rudplph (2018), International Journal of Computerized Dentistry: 97-105
- 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