Trials
Search / Trial NCT06426550

Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IV

Launched by UNIVERSIDADE FEDERAL FLUMINENSE · May 17, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

Periodontal Diseases Periodontal Pocket Laser Therapy Methylene Blue

ClinConnect Summary

This clinical trial is investigating new laser therapies to treat advanced gum disease, known as periodontitis. Specifically, it is looking at two types of laser treatments combined with standard gum disease care to see how well they work in improving the health of the gums and mouth bacteria. The trial will involve 20 adults with significant gum disease, who will be divided into two groups. One group will receive the new laser treatments, while the other will receive a placebo, which is a treatment with no active ingredients. Researchers will check participants’ gum health before treatment and again three months later.

To join the study, participants need to be adults with severe periodontitis, meaning they have many areas of gum disease affecting their teeth. They should have specific measurements of gum health that show a need for treatment. However, those who have had recent gum treatments, are pregnant, or have certain health conditions like diabetes or osteoporosis cannot participate. This trial is currently looking for volunteers, and it aims to provide insights into better ways to treat gum disease using innovative laser technology.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult participants with periodontal disease;
  • Four or more periodontal sites with PPD≥6 mm and CAL≥5 mm, non-adjacent;
  • Generalized periodontitis, with more than 30% of the sites involved (Caton et al., 2018);
  • Stages III and IV of periodontal disease (Caton et al., 2018);
  • Exclusion Criteria:
  • Participants with hypersensitivity to the components of the 0.005% methylene blue gel;
  • Received periodontal treatment in the last six months;
  • Drugs (alcoholics, use of anti-inflammatories and antibiotics in the last 3 months);
  • Any evidence of systemic modifying factors which may directly interfere with the completion of the work (bias), such as:
  • Pregnant and breastfeeding women;
  • Hormone replacement therapy;
  • Smoking;
  • Hyperglycemia;
  • Osteoporosis;
  • Diagnosed with HIV+ or AIDS.

Trial Officials

Gabriela AC Camargo, Doctor

Principal Investigator

Fluminense Federal University

About Universidade Federal Fluminense

Universidade Federal Fluminense (UFF) is a prestigious Brazilian public university renowned for its commitment to academic excellence and innovation in research. As a clinical trial sponsor, UFF leverages its multidisciplinary expertise and state-of-the-art facilities to advance medical knowledge and improve patient outcomes. The institution fosters collaboration between researchers, healthcare professionals, and industry partners, ensuring rigorous ethical standards and adherence to regulatory requirements in the conduct of clinical trials. UFF's dedication to scientific inquiry and community health positions it as a leading contributor to the advancement of clinical research in Brazil and beyond.

Locations

Nova Friburgo, Rio De Janeiro, Brazil

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0