Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06724107

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

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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