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

NCT06877546 | Active Not Recruiting

• 1 other identifier: PhoSS
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sjögren's syndrome; xerostomia; aPDT; antibacterial; photodynamic therapy; photobiomodulation

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Subjective dry mouth (xerostomia) follow-up

  3 months

Study Arms (1)

Lumoral® Treatment

EXPERIMENTAL

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

Device: Lumoral treatment

Interventions

Lumoral treatment 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.

Lumoral® Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koite Health Oy: lead
• Metropolia University of Applied Sciences: collaborator

Study Sites (1)

Metropolia University of applied sciences

Helsinki, Finland

Location

Related Publications (7)

• 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.

  PMID: 35743485 BACKGROUND

• Jao 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.

  PMID: 37799910 BACKGROUND

• Lahteenmaki 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.

  PMID: 35723308 BACKGROUND

• Negrini 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.

  PMID: 34100160 BACKGROUND

• Nikinmaa 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.

  PMID: 34063662 BACKGROUND

• Pakarinen 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.

  PMID: 36354651 BACKGROUND

• Tashbayev 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.

  PMID: 28883442 BACKGROUND

Related Links

• The European Code of Conduct for Research Integrity - Revised Edition 2023. Berlin: All European Academies.
• 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.2021.20080

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Saila Pakarinen, DDS

  Metropolia University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: May 24, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)