Photofunctionalization With UVC

ConditionImplant Site Reaction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversidad Complutense de Madrid

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: UVC groupExperimental treatment 1 intervention

Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Bone regeneration

Bone implant contact (BIC) Histotogic parameter in percentage

Time frame

3 months

Secondary outcomes

ISQ and marginal bone loss

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

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Complutense de Madrid

Lead sponsor

Source ClinicalTrials.gov

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