The Use of Bone-, Tooth- and Mucosa- Supported Stereolithographic Guides for Dental Implant Placement (stereolitho)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01027442
Recruitment Status : Completed
First Posted : December 8, 2009
Last Update Posted : November 27, 2013
Risus medikal, Thommen medical (Switzerland) Turkish partner
Dentsply Implants Manufacturing GmbH
Information provided by:
Istanbul University

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Stereolithography Dental Implants Prosthesis Device: Mucosa-supported single-type guides Device: Bone-supported guides Device: Dental Implants Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Conventional Versus Computer Aided Implantology
Study Start Date : July 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Placebo Comparator: Conventional implant placement method
The patients in ths group will be treated by conventional, "free-hand" implant placement
Device: Dental Implants
Dental implants placed via conventional free-hand method
Other Names:
  • Thommen Medical SPI, Waldenburg, Switzerland
  • Frident Xixe, dentsply Friadent-Turkey
Active Comparator: Computer-guidedimplant placement
In this group, the patients will be treated by implants placed via computer generated SLA guides
Device: Mucosa-supported single-type guides
Compute generated Mucosa-supported single-type guides
Other Name: Simplant, SAFEsystem, Materialise Dental, Leuven , Belgium
Device: Bone-supported guides
Computer generated, Multiple type Bone-supported guides
Other Name: Aytasarim, Classic. Odtu-Kosgep, Ankara, Turkey

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01027442

Department of Oral Implantology, Faculty of Dentistry, ıstnabul University
Istanbul, Capa, Turkey, 34390
Sponsors and Collaborators
Istanbul University
Risus medikal, Thommen medical (Switzerland) Turkish partner
Dentsply Implants Manufacturing GmbH
Study Chair: Tayfun Ozdemir, Prof.Dr. Section head: Department of Implantology, Faculty of Dentistry, Istabul University
Principal Investigator: Volkan Arısan, Dr.Med.Dent Department of Oral Implantology, Istanbul University
Study Director: Cuneyt Z Karabuda, Prof.Dr. Department of Oral Implantology, Istanbul University

Publications of Results:
Responsible Party: Istanbul University, Faculty of Dentistry Identifier: NCT01027442     History of Changes
Other Study ID Numbers: Stereolithographic guides
Implant with SLA ( Other Identifier: Istanbul University, Faculty of Dentistry )
First Posted: December 8, 2009    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: June 2007

Keywords provided by Istanbul University:
Dental implants,
logistic regression analysis