Actively Recruiting
Effect of Photofunctionalization With on Titanium Dental Implants A Pilot Study
Led by Universidad Complutense de Madrid · Updated on 2024-12-09
60
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a pilot clinical trial to compare the placement of standard titanium dental implants with implants treated using a surface photofunctionalization technique based on ultraviolet C radiation (UVC). The study aims to evaluate whether this UVC treatment accelerates bone growth on the implant surface and increases the amount of bone bonding, potentially allowing for earlier loading of the implants. This randomized, double-blind, controlled study is carried out at the Complutense University of Madrid in their Master's Degree in Oral Surgery and Implantology program. Participants receive either photofunctionalized implants treated with UVC (experimental group) or standard non-photofunctionalized implants (control group). The study evaluates implant stability quotient (ISQ) at weekly intervals up to four weeks after surgery to assess bone integration and determine if immediate loading of implants can occur before four weeks. Both native bone and grafted bone sites are included. The trial monitors bone regeneration over three months and ISQ and marginal bone loss over twelve months. During the study, patients undergo implant placement surgery with or without bone or soft tissue regeneration. Follow-up assessments include ISQ measurements at 1, 2, 3, and 4 weeks, with bone regeneration evaluated at three months and additional monitoring of marginal bone loss for up to twelve months. The study tracks implant stability and bone healing to provide insights on reducing implant loading times. Total participation lasts at least one year to capture long-term outcomes. Safety and adherence are monitored throughout the study period.
CONDITIONS
Brief Title
Photofunctionalization With UVC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Patients requiring dental implant surgery with or without bone or soft tissue regeneration surgery
- Acceptance of the informed consent document
You will not qualify if you...
- Subjects with systemic diseases causing untreated or uncontrolled haemostasis or coagulation problems
- Subjects with active infectious diseases such as tuberculosis, HIV, syphilis, or hepatitis
- Patients treated with monoclonal antibodies, bisphosphonates, chemotherapy, or long-term corticoids
- Patients with alcoholism or drug addiction
- Pregnant or breastfeeding women
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.
1 visit (in-person)
Duration - Up to 4 weeks
Participants undergo dental implant surgery with either photofunctionalised (UVC) implants or non-photofunctionalised implants. The treatment aims to evaluate and compare implant stability and bone regeneration.
Visits at 1 week, 2 weeks, 3 weeks, and 4 weeks post-surgery
Duration - Up to 12 months
Participants are monitored for bone regeneration and implant stability, including long-term assessment of marginal bone loss.
Periodic visits for assessments up to 12 months
Trial Site Locations
Total: 1 location
1
Jesus Torres
Madrid, Spain
Actively Recruiting
Research Team
J
jesus gd 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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