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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-24

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Sjogren's syndrome is a chronic autoimmune disease that has a holistic impact on a patient's health. The most significant consequence in terms of oral health is the destruction of the salivary glands by the autoimmune reaction, leading to salivary gland failure and consequently dry mouth with reduced saliva secretion. Decreased saliva secretion predisposes to a number of oral health problems, and patients with Sjogren's syndrome are therefore at risk for conditions such as caries and periodontitis, an inflammatory periodontal disease. Regular visits to an oral health professional and good oral hygiene and eating habits and habits promote and maintain oral health. Treatments for dry mouth symptoms associated with Sjogren's syndrome aim to relieve oral symptoms by preserving, replacing and stimulating salivary gland secretion in ways that relieve local inflammation.

Regular home-use of specially designed antibacterial photodynamic therapy device in addition to standard oral self-care has been shown to destroy oral disease-causing bacteria in a way that bacteria cannot develop resistance to. In addition, the treatment method also stimulates saliva production through photobiomodulation. The aim of our study is therefore to investigate, by means of a clinical measurement, whether the regular use of the antibacterial photodynamic therapy device as part of oral self-care can have an effect on the amount of stimulated saliva secretion of a patient with Sjogren's syndrome during the ten-week study period. The aim is also to describe, by means of a questionnaire measuring the subjective symptoms of dry mouth, whether the treatment has an effect on the frequency of the typical symptoms of xerostomia.

Conditions

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Sjogren Syndrome Xerostomia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Lumoral® Treatment

Lumoral® Treatment is an adjunctive treatment to normal oral hygiene routines

Group Type EXPERIMENTAL

Lumoral treatment

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No