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

Dental Implants Clinical Trial

— stereolitho  

Official title:

Conventional Versus Computer Aided Implantology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027442
• Other study ID #: Stereolithographic guides
• Secondary ID: Implant with SLA
• Status: Completed
• Phase: N/A
• First received: December 7, 2009
• Last updated: November 26, 2013
• Start date: July 2008
• Est. completion date: December 2009

Study information

• Verified date: June 2007
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy patient with at leat one edentusous 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dental Implants
• Prosthesis
• Stereolithography

Intervention

Device:
• Mucosa-supported single-type guides
Compute generated Mucosa-supported single-type guides
• Bone-supported guides
Computer generated, Multiple type Bone-supported guides
• Dental Implants
Dental implants placed via conventional free-hand method

Locations

Country	Name	City	State
Turkey	Department of Oral Implantology, Faculty of Dentistry, istnabul University	Istanbul	Capa

Sponsors (3)

Lead Sponsor	Collaborator
Istanbul University	Dentsply Implants Manufacturing GmbH, Risus medikal, Thommen medical (Switzerland) Turkish partner

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Arisan V, Bölükbasi N, Öksüz 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. — View Citation

Arisan V, Karabuda CZ, Mumcu E, Özdemir 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. — View Citation

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) — View Citation

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. — View Citation