The Use of Bone-, Tooth- and Mucosa- Supported Stereolithographic Guides for Dental Implant Placement (stereolitho)
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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 |
| 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:
|
|
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 |
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| Turkey | |
| Department of Oral Implantology, Faculty of Dentistry, ıstnabul University | |
| Istanbul, Capa, Turkey, 34390 | |
| 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: | June 7, 2010 |
| 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 May 23, 2013