SURGICAL GUIDES EFFECTIVENESS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical Guide.
- Who it may be relevant to
- Registry conditions: Atrophic Maxilla. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PRECISION OF SURGICAL GUIDES FOR PLACEMENT OF EXTRA-LARGE DENTAL IMPLANTS. A PILOT STUDY
Overview
The use of zygomatic implants is a technique that is becoming more and more widespread in daily clinical practice, however, few professionals feel safe and confident in performing this type of procedure. We therefore believe that a line of research focused on simplifying this technique will have an extraordinary impact on the safety of both patients and surgeons. Currently, new surgical guides have emerged that guarantee greater precision in the placement of zygomatic implants. However, no comparative clinical studies have yet been performed to evaluate the degree of accuracy of guided implant placement compared to the conventional freehand technique.
Detailed description
The primary objective of the study is to study the accuracy of the use of guided surgical splints compared to traditional freehand zygomatic implant placement.
The secondary objectives are:
* To compare the magnitude of variations depending on implant length by superimposing postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software. * To compare the magnitude of the variations depending on the location of the implant by superimposing postoperative and postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software. * To assess the clinical relevance of cogomatic implant placement using guided surgical splinting on pain parameters and surgical time.
Interventions
- Procedure Surgical Guide
Placing extralarge implats for rahabilitation atrophic maxilla
Primary outcome measures
- Accuracy of Surgical Guides in implant placement [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Age between 18-80 years of age, patients who sign the informed consent form and patients who consent to undergo preoperative and postoperative orthopantomography and CT scans.
Exclusion criteria
- Smoking (more than 10 cigarettes per day).
- Alcoholism (more than 25g/day in women and more than 40g/day in men according to WHO criteria),
- Oncological treatment (history of treatment in the last 6 months or current treatment with chemotherapy or radiotherapy).
- History of head and neck radiotherapy.
- Allergic to anesthetics or antibiotics.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 2 centers
- Jesus — Madrid
- UCM — Madrid
Identifiers
NCT: NCT06737289 · C.I. 24/728-E