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

This study has been completed.
Sponsor:
Collaborators:
Risus medikal, Thommen medical (Switzerland) Turkish partner
Dentsply Implants Manufacturing GmbH
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT01027442
First received: December 7, 2009
Last updated: November 26, 2013
Last verified: June 2007
  Purpose

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.


Condition Intervention
Stereolithography
Dental Implants
Prosthesis
Device: Mucosa-supported single-type guides
Device: Bone-supported guides
Device: Dental Implants

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Conventional Versus Computer Aided Implantology

Further study details as provided by Istanbul University:

Enrollment: 61
Study Start Date: July 2008
Study Completion Date: December 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027442

Locations
Turkey
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
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
  More Information

Publications:
Responsible Party: Istanbul University, Faculty of Dentistry
ClinicalTrials.gov Identifier: NCT01027442     History of Changes
Other Study ID Numbers: Stereolithographic guides, Implant with SLA
Study First Received: December 7, 2009
Last Updated: November 26, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Istanbul University:
Stereolithography
Dental implants,
Prosthetics
positioning-errors
logistic regression analysis

ClinicalTrials.gov processed this record on October 21, 2014