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NCT Number: NCT06724107

Photofunctionalization With UVC

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jesus Torres

Madrid, Spain

Location status: Recruiting

Location contact

Jesus Torres, PhD

CONTACT

[email protected]

653050071 ext. +34

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Bone regeneration

    Time frame: 3 months

    Bone implant contact (BIC) Histotogic parameter in percentage

Secondary outcomes

  1. ISQ and marginal bone loss

    Time frame: 12 months

    Implant stability quotient and marginal bone loss measure with X-rays (quantitative parameter)

Study contacts

Contact information is provided by the study sponsor or research team.

jesus gd torres, PhD

CONTACT

[email protected]

+34653050071 ext. 34

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Acronym: EPID

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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