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Search / Trial NCT05698823

Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis

Launched by KOITE HEALTH OY · Jan 16, 2023

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Lumoral Lumorinse Periodontitis Anti Bacterial Photodynamic Therapy A Pdt Plaque A Mmp 8 Photobiomodulation

ClinConnect Summary

This clinical trial is looking at a new method called the Lumoral method to help manage chronic periodontitis, particularly in patients with more advanced stages (III and IV) of the disease. Periodontitis is a serious gum infection that can lead to tooth loss if not treated. The goal of the study is to see if using this method regularly at home can improve control of plaque (the sticky film of bacteria on teeth) and help keep the gums healthy over time. It may also have some benefits for the tissues in the mouth due to a special light treatment involved.

To participate in this trial, you need to be at least 18 years old, have a diagnosis of stage III or IV periodontitis, and have at least 20 teeth, including implants. You'll need to agree to follow the treatment plan and avoid other oral hygiene products during the study. However, if you have certain conditions like active smoking or other health issues that could affect your gums, or if you've had recent dental treatments, you may not be eligible. If you join the study, you can expect to use the Lumoral method as part of your oral care routine and contribute to important research that could improve gum disease management for others in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Periodontal disease stage III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss.
  • ≥ 18 years old
  • Presence of ≥20 teeth, including implants
  • Agreement to participate in the study and to sign a written consent form
  • Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol
  • Exclusion Criteria:
  • Grade A or C periodontitis
  • Presence of any physical limitation or restriction that might restrict Lumoral use
  • Pregnancy or lactation
  • Active smoking
  • Medicated diabetes mellitus (DM)
  • Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
  • Use of antibiotics within 4 weeks week prior study
  • Periodontal treatment within 3 months prior study
  • Removable major prosthesis or major orthodontic appliance
  • A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment

About Koite Health Oy

Koite Health Oy is a pioneering clinical trial sponsor dedicated to advancing healthcare through innovative research and development. Based in Finland, the company specializes in designing and managing clinical trials that focus on cutting-edge therapies and medical technologies. With a commitment to improving patient outcomes, Koite Health Oy leverages a team of experienced professionals and robust methodologies to ensure the highest standards of quality and compliance throughout the research process. By fostering collaborations with healthcare providers and stakeholders, Koite Health Oy aims to bring transformative solutions to the market, enhancing the efficacy and accessibility of treatments for various medical conditions.

Locations

Kaunas, , Lithuania

Patients applied

0 patients applied

Trial Officials

Timo Sorsa, Professor

Study Director

University of Helsinki

Tommi Pätilä, Docent

Study Chair

Koite Health

Ingrida Marija Pacauskiene, Doctor

Principal Investigator

Lithuanian University of Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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