Photofunctionalization With UVC (EPID)

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: Implant Site Reaction
• Intervention / Treatment: Radiation: UVC

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jesus gd torres, PhD; Phone Number: 34 +34653050071; Email: jesus.torres@ucm.es

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Jesus Torres
    • Contact: Jesus Torres, PhD; Phone Number: +34 653050071; Email: jesus.torres@ucm.es

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Bone implant contact (BIC) Histotogic parameter in percentage	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Study Director: isabel leco, PhD, UCM

Study record dates

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: dental implants; UVC; ISQ (implant stability quotient); inmediate loading
• 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