Photofunctionalization With UVC (EPID)

December 6, 2024 updated by: Jesús Torres García Denche, Universidad Complutense de Madrid

Effect of Photofunctionalization With on Titanium Dental Implants. A Pilot Sutdy

Summary:

Objective: The general objective is to compare the placement of standard implants with a surface photofunctionalization technique based on ultraviolet C radiation (UVC), having as working hypothesis that this photofunctionalization will accelerate the bone apposition on the implant surface and increase the amount of bone that binds to the implant, making it possible to load these photofunctionalized implants in less time.

Design: Pilot, clinical, randomized, prospective, controlled, single-center, prospective study.

Scope of the study: Master's Degree in Oral Surgery and Implantology. Faculty of Dentistry. Complutense University of Madrid.

Subjects of the study: patients attending the Master's Degree in Oral Surgery and Implantology for rehabilitation with dental implants, regardless of the sector in which they have missing teeth.

Key words: ISQ (implant stability quotient), inmediate loading, UVC, dental implants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain
        • Recruiting
        • Jesus Torres
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subjects with systemic diseases leading to untreated or uncontrolled haemostasis or coagulation disturbances.
  • Subjects with active infectious diseases (tuberculosis, HIV, syphilis, hepatitis, etc).
  • Patients under pharmacological treatment with monoclonal antibodies, bisphosphonates, chemotherapy or prolonged treatment with corticoids.
  • Patients with alcoholism or drug addiction.
  • Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UVC group
photofunctionalised (study group) implants
Radiation: UVC
It is proposed to evaluate and compare the ISQ at 1 week, 2 weeks, 3 weeks and 4 weeks in patients undergoing implant placement surgery by comparing photofunctionalised (study group) and non-photofunctionalised (control group) implants in both native bone and grafted bone. To assess whether immediate loading can be carried out before 4 weeks and how long the waiting time for implant loading can be reduced, by performing predictability curves.
Placebo Comparator: Control group
non-photofunctionalised (control group) implants
Radiation: UVC
It is proposed to evaluate and compare the ISQ at 1 week, 2 weeks, 3 weeks and 4 weeks in patients undergoing implant placement surgery by comparing photofunctionalised (study group) and non-photofunctionalised (control group) implants in both native bone and grafted bone. To assess whether immediate loading can be carried out before 4 weeks and how long the waiting time for implant loading can be reduced, by performing predictability curves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone regeneration
Time Frame: 3 months
Bone implant contact (BIC) Histotogic parameter in percentage
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ISQ and marginal bone loss
Time Frame: 12 months
Implant stability quotient and marginal bone loss measure with X-rays (quantitative parameter)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Investigators

  • Study Director: isabel leco, PhD, UCM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 12, 2024

Primary Completion (Estimated)

June 20, 2025

Study Completion (Estimated)

April 20, 2026

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C.I. 23/523-EC_P

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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