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

November 26, 2013 updated by: Istanbul University

Conventional Versus Computer Aided Implantology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Capa
      • Istanbul, Capa, Turkey, 34390
        • Department of Oral Implantology, Faculty of Dentistry, ıstnabul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Simplant, SAFEsystem, Materialise Dental, Leuven , Belgium
Device: Bone-supported guides
Computer generated, Multiple type Bone-supported guides
Other Names:
  • Aytasarim, Classic. Odtu-Kosgep, Ankara, Turkey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Collaborators

Dentsply Implants Manufacturing GmbH
Risus medikal, Thommen medical (Switzerland) Turkish partner

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 7, 2009

First Posted (Estimate)

December 8, 2009

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Stereolithographic guides
  • Implant with SLA (Other Identifier: Istanbul University, Faculty of Dentistry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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