Actively Recruiting
Precision of Surgical Guides for Placement of Extra-Large Dental Implants: A Pilot Study
Led by Universidad Complutense de Madrid · Updated on 2024-12-20
20
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of using guided surgical splints versus the traditional freehand method for placing zygomatic implants in patients with atrophic maxilla. The study aims to improve the safety and precision of implant placement for both patients and surgeons, as currently few professionals feel confident performing this procedure. This pilot study also explores how implant length and location affect placement accuracy and examines the impact on pain and surgical time. Participants will be randomly assigned to one of two groups: one receiving zygomatic implants placed using a surgical guide, and the other undergoing the conventional freehand implant placement. The study uses advanced imaging software to compare postoperative CT scans for assessing implant position accuracy. This interventional, double-blind trial begins with preoperative and postoperative imaging to evaluate the outcomes over a 12-month period. During the study, participants will undergo orthopantomography and CT scans before and after the implant surgery. Researchers will measure the precision of implant placement, pain levels, and surgery duration. The study includes follow-up assessments to monitor these outcomes and ensure participant safety. Total participation lasts at least 12 months to allow for thorough evaluation of the surgical techniques.
CONDITIONS
Brief Title
SURGICAL GUIDES EFFECTIVENESS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Patients who sign the informed consent form
- Patients who agree to undergo preoperative and postoperative orthopantomography and CT scans
You will not qualify if you...
- Smoking more than 10 cigarettes per day
- Alcohol consumption over 25g/day for women or 40g/day for men according to WHO criteria
- History of oncological treatment within the last 6 months or current chemotherapy or radiotherapy
- History of head and neck radiotherapy
- Allergy to anesthetics or antibiotics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day for surgery with immediate post-operative care
Participants undergo placement of extra-large dental implants either using a surgical guide or traditional freehand technique.
1 surgery visit (in-person) and immediate post-operative care
Duration - 12 months
Participants are monitored over 12 months to assess the accuracy of implant placement and recovery outcomes.
Periodic follow-up visits during 12 months
Trial Site Locations
Total: 2 locations
1
Jesus
Madrid, Spain, 28040
Actively Recruiting
2
UCM
Madrid, Spain, 28040
Actively Recruiting
Research Team
J
Jesus Torres, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here