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Completed

NCT Number: NCT01027442

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral Implantology, Faculty of Dentistry, ıstnabul University

Istanbul, Capa, 34390, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mucosa-supported single-type guides

Device

Compute generated Mucosa-supported single-type guides

Other names: Simplant, SAFEsystem, Materialise Dental, Leuven , Belgium

Bone-supported guides

Device

Computer generated, Multiple type Bone-supported guides

Other names: Aytasarim, Classic. Odtu-Kosgep, Ankara, Turkey

dental implants

Device

Dental implants placed via conventional free-hand method

Other names: Thommen Medical SPI, Waldenburg, Switzerland, Frident Xixe, dentsply Friadent-Turkey

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

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

Registry information

Official study title

Conventional Versus Computer Aided Implantology

Acronym: stereolitho

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 8, 2009
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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