Photofunctionalization With UVC

NCT06724107 | Recruiting

• 1 other identifier: C.I. 23/523-EC_P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Implant Site Reaction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bone regeneration

  Bone implant contact (BIC) Histotogic parameter in percentage

  3 months

Secondary Outcomes (1)

• ISQ and marginal bone loss

  12 months

Study Arms (2)

UVC group

EXPERIMENTAL

photofunctionalised (study group) implants

Radiation: UVC

Control group

PLACEBO COMPARATOR

non-photofunctionalised (control group) implants

Radiation: UVC

Interventions

UVC RADIATION

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.

Control group; UVC group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Jesus Torres

Madrid, Spain

RECRUITING

Study Officials

• isabel leco, PhD

  UCM

  STUDY DIRECTOR

Central Study Contacts

jesus gd torres, PhD

CONTACT

+34653050071; jesus.torres@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: December 9, 2024
• Study Start: December 12, 2024
• Primary Completion: June 20, 2025
• Study Completion: April 20, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-11

Locations

ES (1)