Photofunctionalization With UVC

NCT ID: NCT06724107

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-12

Study Completion Date

2026-04-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Implant Site Reaction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ISQ (implant stability quotient) inmediate loading UVC dental implants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
blinding

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

UVC group

photofunctionalised (study group) implants

Group Type EXPERIMENTAL

UVC

Intervention Type 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

non-photofunctionalised (control group) implants

Group Type PLACEBO_COMPARATOR

UVC

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jesús Torres García Denche

Associate Profesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

isabel leco, PhD

Role: STUDY_DIRECTOR

UCM

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jesus Torres

Madrid, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

jesus gd torres, PhD

Role: CONTACT

Phone: +34653050071

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jesus Torres, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C.I. 23/523-EC_P

Identifier Type: -

Identifier Source: org_study_id