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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nova Friburgo, Rio De Janeiro, Brazil
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0