Sjogren SyndromeNCT06877546
Photodynamic Treatment as Part of Oral Healthcare on Persons With Sjögren's Syndrome
A study testing Lumoral treatment in people with Sjogren Syndrome and Xerostomia, run by Koite Health Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren Syndrome, Xerostomia
- What is being tested?
- Lumoral treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFinland
- Study dates
- 24 May 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Sjogren Syndrome, Xerostomia
- Being tested
- Lumoral treatment
- Keywords
- Sjögren's syndrome, xerostomia, aPDT, antibacterial, photodynamic therapy, photobiomodulation
- Medical subject headings
- Sjogren's Syndrome, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumoral treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Lumoral® Treatment | Experimental | Lumoral® Treatment is an adjunctive treatment to normal oral hygiene routines Receives: Device: Lumoral treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulated saliva
Measurement of stimulated saliva is performed at the baseline and study end visits. On both visits, the stimulated saliva is measured twice: before and after the investigational device use.
Stimulated saliva production is measured in a frontal, sitting, or semi-sitting position by having the patient chew a piece of paraffin, for example, for one minute. During this time, the saliva is swallowed. The patient then continues to chew for five minutes, during which time the saliva accumulated in the mouth is drained into a measuring cup.
The volume of stimulated saliva is measured in milliliters. The measurements will be analyzed using quantitive methods.
Measured: 3 months
Secondary outcomes (1)
Subjective dry mouth (xerostomia) follow-up
Xerostomia questionnaire.
Study subjects are asked to fill in a questionnaire at the study end visit to determine the frequency of xerostomia symptoms during the 3-month study period. The questionnaire is designed to ask a set of pre-set questions, which are answered on a 5-point Likert scale (1, not at all true - 5, completely true).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start24 May 2025
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sjogren SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koite Health Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Metropolia University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Saila Pakarinen, DDS, Principal investigator, Metropolia University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877546
- Sponsor's protocol ID
- PhoSS
- Status last verified
- Aug 2025
- First submitted
- 10 Mar 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrandez-Pujante A, Pons-Fuster E, Lopez-Jornet P. Efficacy of Photobiomodulation in Reducing Symptomatology and Improving the Quality of Life in Patients with Xerostomia and Hyposalivation: A Randomized Controlled Trial. J Clin Med. 2022 Jun 14;11(12):3414. doi: 10.3390/jcm11123414.
PubMed 35743485Jao Y, Ding SJ, Chen CC. Antimicrobial photodynamic therapy for the treatment of oral infections: A systematic review. J Dent Sci. 2023 Oct;18(4):1453-1466. doi: 10.1016/j.jds.2023.07.002. Epub 2023 Jul 11.
PubMed 37799910Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.
PubMed 35723308Negrini S, Emmi G, Greco M, Borro M, Sardanelli F, Murdaca G, Indiveri F, Puppo F. Sjogren's syndrome: a systemic autoimmune disease. Clin Exp Med. 2022 Feb;22(1):9-25. doi: 10.1007/s10238-021-00728-6. Epub 2021 Jun 7.
PubMed 34100160Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052.
PubMed 34063662Pakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206.
PubMed 36354651Tashbayev B, Rusthen S, Young A, Herlofson BB, Hove LH, Singh PB, Rykke M, Aqrawi LA, Chen X, Utheim OA, Utheim TP, Palm O, Jensen JL. Interdisciplinary, Comprehensive Oral and Ocular Evaluation of Patients with Primary Sjogren's Syndrome. Sci Rep. 2017 Sep 7;7(1):10761. doi: 10.1038/s41598-017-10809-w.
PubMed 28883442
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Treatment as Part of Oral Healthcare on Persons With Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT06877546
- Acronym / sponsor ID
- PhoSS
- Conditions
- Sjogren Syndrome, Xerostomia
- Keywords
- Sjögren's syndrome, xerostomia, aPDT, antibacterial, photodynamic therapy, photobiomodulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Koite Health OyIndustry (pharma, biotech, devices)
- Collaborators
- Metropolia University of Applied Sciences
- Study start
- 24 May 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumoral® Treatment | Experimental | Device: Lumoral treatmentLumoral® Treatment is an adjunctive treatment to normal oral hygiene routines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumoral treatmentLumoral® 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. | Device | Lumoral® Treatment |
Primary outcome
Stimulated saliva
Time frame: 3 months
Measurement of stimulated saliva is performed at the baseline and study end visits. On both visits, the stimulated saliva is measured twice: before and after the investigational device use. Stimulated saliva production is measured in a frontal, sitting, or semi-sitting position by having the patient chew a piece of paraffin, for example, for one minute. During this time, the saliva is swallowed. The patient then continues to chew for five minutes, during which time the saliva accumulated in the mouth is drained into a measuring cup. The volume of stimulated saliva is measured in milliliters. The measurements will be analyzed using quantitive methods.
1 secondary outcome
Subjective dry mouth (xerostomia) follow-up
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 35743485Ferrandez-Pujante A, Pons-Fuster E, Lopez-Jornet P. Efficacy of Photobiomodulation in Reducing Symptomatology and Improving the Quality of Life in Patients with Xerostomia and Hyposalivation: A Randomized Controlled Trial. J Clin Med. 2022 Jun 14;11(12):3414. doi: 10.3390/jcm11123414.
- Background: PubMed 37799910Jao Y, Ding SJ, Chen CC. Antimicrobial photodynamic therapy for the treatment of oral infections: A systematic review. J Dent Sci. 2023 Oct;18(4):1453-1466. doi: 10.1016/j.jds.2023.07.002. Epub 2023 Jul 11.
- Background: PubMed 35723308Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.
- Background: PubMed 34100160Negrini S, Emmi G, Greco M, Borro M, Sardanelli F, Murdaca G, Indiveri F, Puppo F. Sjogren's syndrome: a systemic autoimmune disease. Clin Exp Med. 2022 Feb;22(1):9-25. doi: 10.1007/s10238-021-00728-6. Epub 2021 Jun 7.
- Background: PubMed 34063662Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052.
- Background: PubMed 36354651Pakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206.
- Background: PubMed 28883442Tashbayev B, Rusthen S, Young A, Herlofson BB, Hove LH, Singh PB, Rykke M, Aqrawi LA, Chen X, Utheim OA, Utheim TP, Palm O, Jensen JL. Interdisciplinary, Comprehensive Oral and Ocular Evaluation of Patients with Primary Sjogren's Syndrome. Sci Rep. 2017 Sep 7;7(1):10761. doi: 10.1038/s41598-017-10809-w.
- The European Code of Conduct for Research Integrity - Revised Edition 2023. Berlin: All European Academies.Link provided by the sponsor.
- Asan, M. F., Babu, G. S., Castelino, R. L., Rao, K., \& Pandita, V. (2021). Applications of Photobiomodulation Therapy in Oral Medicine-A Review. European Journal of Therapeutics, 27(2), 177-182. https://doi.org/10.5152/eurjther.2021.20080Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saila Pakarinen, DDS principal investigator
Metropolia University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumoral treatment in people with Sjogren Syndrome and Xerostomia, run by Koite Health Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulated saliva (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06877546, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.