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

NCT01027442 | Completed

• 2 other identifiers: Stereolithographic guidesImplant with SLA
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Stereolithography; Dental Implants; Prosthesis

Keywords

Stereolithography; Dental implants,; Prosthetics; positioning-errors; logistic regression analysis

Study Arms (2)

Conventional implant placement method

PLACEBO COMPARATOR

The patients in ths group will be treated by conventional, "free-hand" implant placement

Device: Dental Implants

Computer-guidedimplant placement

ACTIVE COMPARATOR

In this group, the patients will be treated by implants placed via computer generated SLA guides

Device: Mucosa-supported single-type guides; Device: Bone-supported guides

Interventions

Mucosa-supported single-type guides DEVICE

Compute generated Mucosa-supported single-type guides

Also known as: Simplant, SAFEsystem, Materialise Dental, Leuven , Belgium

Computer-guidedimplant placement

Bone-supported guides DEVICE

Computer generated, Multiple type Bone-supported guides

Also known as: Aytasarim, Classic. Odtu-Kosgep, Ankara, Turkey

Computer-guidedimplant placement

Dental Implants DEVICE

Dental implants placed via conventional free-hand method

Also known as: Thommen Medical SPI, Waldenburg, Switzerland, Frident Xixe, dentsply Friadent-Turkey

Conventional implant placement method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy patient with at leat one edentuşous jaw

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead
• Risus medikal, Thommen medical (Switzerland) Turkish partner: collaborator
• Dentsply Implants Manufacturing GmbH: collaborator

Study Sites (1)

Department of Oral Implantology, Faculty of Dentistry, ıstnabul University

Istanbul, Capa, 34390, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 20059416 RESULT

• 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.

  PMID: 20497439 RESULT

• 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.

  PMID: 23377066 RESULT

• 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.

  PMID: 23224042 RESULT

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Tayfun Ozdemir, Prof.Dr.

  Section head: Department of Implantology, Faculty of Dentistry, Istabul University

  STUDY CHAIR

• Volkan Arısan, Dr.Med.Dent

  Department of Oral Implantology, Istanbul University

  PRINCIPAL INVESTIGATOR

• Cuneyt Z Karabuda, Prof.Dr.

  Department of Oral Implantology, Istanbul University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 8, 2009
• Study Start: July 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 27, 2013

Record last verified: 2007-06

Locations

TU (1)