Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
ID06737289

Precision of Surgical Guides for Placement of Extra-Large Dental Implants A Pilot Study Evaluating Guided vs. Freehand Zygomatic Implant Placement for Atrophic Maxilla

Led by Universidad Complutense de Madrid · Updated on 2024-12-20

20

Participants Needed

2

Research Sites

43 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are investigating the accuracy of surgical guides compared to the traditional freehand technique for placing zygomatic implants in patients with atrophic maxilla. This research aims to simplify the surgical procedure, improving safety and confidence for both patients and surgeons. The study also evaluates implant placement variations based on implant length and location, and examines the impact on pain and surgical time. Participants will receive extralarge dental implants placed either using guided surgical splints or the freehand method. The study involves preoperative and postoperative CT scans and orthopantomography to assess the precision of implant placement. Specialized software, including 3DSlicerae and exocadae, will be used to compare variations in implant positioning. Clinical outcomes such as pain and surgery duration will also be monitored. Participants will undergo scans before and after surgery to measure implant placement accuracy over 12 months. Researchers will track surgical outcomes and patient experiences to determine the benefits of guided surgical splints. The study requires informed consent and involves monitoring for safety and treatment precision throughout the follow-up period.

CONDITIONS

Official Title

SURGICAL GUIDES EFFECTIVENESS

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • Patients who sign the informed consent form
  • Patients willing to undergo preoperative and postoperative orthopantomography and CT scans
Not Eligible

You will not qualify if you...

  • Smoking more than 10 cigarettes per day
  • Alcohol consumption above 25g/day for women or 40g/day for men according to WHO criteria
  • 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

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Trial Site Locations

Total: 2 locations

1

Jesus

Madrid, Spain, 28040

Actively Recruiting

2

UCM

Madrid, Spain, 28040

Actively Recruiting

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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

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Precision of Surgical Guides for Placement of Extra-Large Dental Implants A Pilot Study Evaluating Guided vs. Freehand Zygomatic Implant Placement for Atrophic Maxilla | DecenTrialz