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Search / Trial NCT06877546

Photodynamic Treatment as Part of Oral Healthcare on Persons With Sjögren's Syndrome

Launched by KOITE HEALTH OY · Mar 10, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Sjögren&Amp;#39;S Syndrome Xerostomia A Pdt Antibacterial Photodynamic Therapy Photobiomodulation

ClinConnect Summary

This clinical trial is looking at a new treatment option for people with Sjögren's syndrome, a condition that often causes dry mouth (xerostomia). The study will explore whether a special light therapy called antibacterial photodynamic therapy can help relieve dry mouth symptoms when used regularly as part of everyday oral care. By participating, individuals may contribute to finding a potential new way to improve oral health for those affected by this condition.

To be eligible for the study, participants need to be adults aged 18 or older, have Sjögren's syndrome with some saliva production, and be generally healthy. They should not have serious oral health issues or be pregnant or breastfeeding. If you join the study, you can expect to undergo a limited oral examination and receive the photodynamic therapy treatment. The goal is to see if this therapy can make a difference in managing dry mouth, which is an important aspect of living well with Sjögren's syndrome.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult (minimum 18 years of age) person with Sjogren's syndrome, with dry mouth symptoms but some saliva secretion.
  • Otherwise perceived health good, primary Sjögren's syndrome patient.
  • No need for antibiotic prophylaxis at the time of a limited oral examination.
  • Signed written informed consent.
  • Subject's co-operation allows participation in the study.
  • Exclusion Criteria:
  • Pregnancy and/or breastfeeding.
  • Fungal infection in the mouth
  • Poor oral health, such as caries lesions or advanced periodontitis.
  • Fixed dentures, or orthodontics.
  • No saliva secretion.
  • Bisphosphonate drugs, multiple (more than two) medications in use.
  • Participation in other oral health research at the same time.

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

Helsinki, , Finland

Patients applied

0 patients applied

Trial Officials

Saila Pakarinen, DDS

Principal Investigator

Metropolia University of Applied Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported