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

NCT06877546 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-08-08

No results posted yet for this study

Summary

This thesis study will investigate whether the regular use of antibacterial photodynamic therapy can alleviate dry mouth symptoms in patients with Sjogren's syndrome and thus be a potential addition to regular oral self-care habits that promote and maintain oral health.

Conditions

  • Sjogren Syndrome
  • Xerostomia

Interventions

DEVICE

Lumoral treatment

Lumoral® Treatment devices are handed over to study participants on the first visit. The treatment is performed first at the clinic under supervision by the researchers. Treatment is then repeated at home twice a week for 12 weeks. The treatment is started by dissolving one 7 mg Lumorinse® oral tablet in 30 ml amount of pure water. The tablet dissolves in water in one minute, after which the mouthwash is poured into the mouth and swished for 60 seconds. The indocyanine green in the mouthwash adheres to the plaque surface in the teeth and gum line. The mouthwash is then spat out and the mouthpiece of the Lumoral® Treatment device is inserted into the mouth and a light is activated. After 10 minutes, the device turns itself off, after which the mouthpiece is removed from the mouth. Normal oral hygiene routines will then be performed.

Sponsors & Collaborators

  • Metropolia University of Applied Sciences

    collaborator OTHER

  • Koite Health Oy

    lead INDUSTRY

Principal Investigators

  • Saila Pakarinen, DDS · Metropolia University of Applied Sciences

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-24
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06877546 on ClinicalTrials.gov