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

Istanbul University

Status: Completed

Conditions: Stereolithography; Dental Implants; Prosthesis

Treatments: Device: Dental Implants; Device: Mucosa-supported single-type guides; Device: Bone-supported guides

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01027442

Stereolithographic guides

Implant with SLA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

61 participants in 2 patient groups, including a placebo group

Conventional implant placement method

Placebo Comparator group

Description:

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

Treatment:

Device: Dental Implants

Computer-guidedimplant placement

Active Comparator group

Description:

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

Treatment:

Device: Bone-supported guides

Device: Mucosa-supported single-type guides