Clinical trial NCT01027442: The Use of Bone-, Tooth- and Mucosa- Supported Stereolithographic Guides for Dental Implant Placement
Official title: Conventional Versus Computer Aided Implantology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stereolithography
Dental Implants
Prosthesis
Keywords: Stereolithography
Dental implants,
Prosthetics
positioning-errors
logistic regression analysis
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Risus medikal, Thommen medical (Switzerland) Turkish partner
name: Dentsply Implants Manufacturing GmbH
First posted: 2009-12-08
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction:

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.


Eligibility criteria: Inclusion Criteria:

* Healthy patient with at leat one edentuşous jaw

Exclusion Criteria:

* Patients with at least one edentulous jaw with healthy systemic and oral status without severe alveolar bone athrophy, major alveolar hard and/or soft tissue deficiency, mouth opening restriction, heavy smoking (\> 10 /per day) and parafunctional habits were included in the study.
* 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Department of Oral Implantology, Faculty of Dentistry, ıstnabul University
state: Capa
Study officials:
affiliation: Section head: Department of Implantology, Faculty of Dentistry, Istabul University
name: Tayfun Ozdemir, Prof.Dr.
role: STUDY_CHAIR
affiliation: Department of Oral Implantology, Istanbul University
name: Volkan Arısan, Dr.Med.Dent
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oral Implantology, Istanbul University
name: Cuneyt Z Karabuda, Prof.Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.