The Use of Bone-, Tooth- and Mucosa- Supported Stereolithographic Guides for Dental Implant Placement
NCT ID: NCT01027442
Last Updated: 2013-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
61 participants
INTERVENTIONAL
2008-07-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The use stereolithographic (SLA) guides may provide significant benefits in simultaneous placement of multiple implants, especially in large edentulous areas lacking anatomic landmarks for surgical reference. Planning of the implant positions prior to surgery may shorten the duration of the surgery spent by exploring and determining the suitable implant location on the edentulous alveolar crest in the standard technique . Previous studies have demonstrated the use of many SLA guide in this manner, however; most were designed to be used as placed on the alveolar crest (bone-supported) following a flap exposure, and there was no depth-control of the osteotomy drills. Further advances in stereolithography allowed flapless surgeries to be performed via mucosa-supported guides (Rosenfeld, et al. 2006c, Tardieu, et al. 2007). The use of these guides eliminates not only the time required for incision and flap exposure but post-operative patient morbidity and discomfort may also be reduced, due to the non-invasive nature of the procedure. The aim of this study is to investigate the accuracy, surgical and post-operative complications and post-loading outcomes of implants placed by the conventional and aforementioned computer-aided methods.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conventional implant placement method
The patients in ths group will be treated by conventional, "free-hand" implant placement
Dental Implants
Dental implants placed via conventional free-hand method
Computer-guidedimplant placement
In this group, the patients will be treated by implants placed via computer generated SLA guides
Mucosa-supported single-type guides
Compute generated Mucosa-supported single-type guides
Bone-supported guides
Computer generated, Multiple type Bone-supported guides
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mucosa-supported single-type guides
Compute generated Mucosa-supported single-type guides
Bone-supported guides
Computer generated, Multiple type Bone-supported guides
Dental Implants
Dental implants placed via conventional free-hand method
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* All patients were initially evaluated for the suitability of an implant supported fixed prosthesis and any patients unsuitable for such prosthetic superstructure (i.e. severe hard and soft tissue athrophy, insufficient hygiene practice etc.) were excluded.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Risus medikal, Thommen medical (Switzerland) Turkish partner
UNKNOWN
Dentsply Implants Manufacturing GmbH
INDUSTRY
Istanbul University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Faculty of Dentistry
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tayfun Ozdemir, Prof.Dr.
Role: STUDY_CHAIR
Section head: Department of Implantology, Faculty of Dentistry, Istabul University
Volkan Arısan, Dr.Med.Dent
Role: PRINCIPAL_INVESTIGATOR
Department of Oral Implantology, Istanbul University
Cuneyt Z Karabuda, Prof.Dr.
Role: STUDY_DIRECTOR
Department of Oral Implantology, Istanbul University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Oral Implantology, Faculty of Dentistry, ıstnabul University
Istanbul, Capa, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Arisan V, Karabuda ZC, Ozdemir T. Accuracy of two stereolithographic guide systems for computer-aided implant placement: a computed tomography-based clinical comparative study. J Periodontol. 2010 Jan;81(1):43-51. doi: 10.1902/jop.2009.090348.
Arisan V, Karabuda CZ, Ozdemir T. Implant surgery using bone- and mucosa-supported stereolithographic guides in totally edentulous jaws: surgical and post-operative outcomes of computer-aided vs. standard techniques. Clin Oral Implants Res. 2010 Sep;21(9):980-8. doi: 10.1111/j.1600-0501.2010.01957.x. Epub 2010 May 24.
Arisan V, Karabuda CZ, Mumcu E, Ozdemir T. Implant positioning errors in freehand and computer-aided placement methods: a single-blind clinical comparative study. Int J Oral Maxillofac Implants. 2013 Jan-Feb;28(1):190-204. doi: 10.11607/jomi.2691.
Arisan V, Bolukbasi N, Oksuz L. Computer-assisted flapless implant placement reduces the incidence of surgery-related bacteremia. Clin Oral Investig. 2013 Dec;17(9):1985-93. doi: 10.1007/s00784-012-0886-y. Epub 2012 Dec 6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Implant with SLA
Identifier Type: OTHER
Identifier Source: secondary_id
Stereolithographic guides
Identifier Type: -
Identifier Source: org_study_id