Photofunctionalization With UVC (EPID)

Universidad Complutense de Madrid

Status: Enrolling

Conditions: Implant Site Reaction

Treatments: Radiation: UVC

Study type: Interventional

Funder types: Other

Identifiers

NCT06724107

C.I. 23/523-EC_P

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

UVC group

Experimental group

Description:

photofunctionalised (study group) implants

Treatment:

Radiation: UVC

Control group

Placebo Comparator group

Description:

non-photofunctionalised (control group) implants

Treatment:

Radiation: UVC