Periodontitis Chronic Generalized ModerateNCT05698823
Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis
A study testing Lumoral Treatment in people with Periodontitis Chronic Generalized Moderate and Periodontitis Chronic Generalized Severe, run by Koite Health Oy at 1 site in Lithuania.
Trial summary
This study is designed to determine the efficacy of the Lumoral method in chronic periodontitis with a targeted group of stage III and IV periodontitis. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Periodontitis Chronic Generalized Moderate, Periodontitis Chronic Generalized Severe
- 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
- 56 participants
- Where
- 1 siteLithuania
- Study dates
- 6 Jun 2023to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontal disease stage III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss.
- ≥ 18 years old
- Presence of ≥20 teeth, including implants
- Agreement to participate in the study and to sign a written consent form
- Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol
Who cannot join
- Grade A or C periodontitis
- Presence of any physical limitation or restriction that might restrict Lumoral use
- Pregnancy or lactation
- Active smoking
- Medicated diabetes mellitus (DM)
- Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
Show all 10Show fewer
- Use of antibiotics within 4 weeks week prior study
- Periodontal treatment within 3 months prior study
- Removable major prosthesis or major orthodontic appliance
- A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology
Kaunas, 50161
About this study
This study is designed to determine the efficacy of the Lumoral method in chronic periodontitis with a targeted group of stage III and IV periodontitis.
Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term.
In addition, the method might have a photobiomodulation effect on periodontal tissues.
Read the detailed description
The Lumoral Treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy (aPDT). The device is used by swishing a specially designed mouth rinse that strongly adheres to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown promising anti-inflammatory responses in addition to plaque reduction.
- Being tested
- Lumoral Treatment
- Keywords
- Lumoral, Lumorinse, Periodontitis, Anti-bacterial photodynamic therapy, aPDT, Plaque, aMMP-8, Photobiomodulation
- Medical subject headings
- Periodontitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumoral TreatmentDevice
The Lumoral treatment -device is a CE-marked antibacterial home-use device for the treatment and prevention of oral diseases caused by bacteria. It is used in combination with a CE-marked mouth rinse called Lumorinse.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use.
All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss. Receives: Device: Lumoral Treatment |
| Control group | No intervention | A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing (BOP)
Improvement in bleeding on probing (BOP)
- A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual)
- Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus
- Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent"
- BOP is reported as the percentage (%) of sites with positive findings
- Calculation formula: number of bleeding sites/ 6 times number of teeth
Measured: 6 months
Secondary outcomes (8)
Active matrix metalloproteinase 8 (aMMP-8)
Change in periodontal inflammation marker aMMP-8
Measured: 6 months
Visible plaque index (VPI)
Change in visible plaque index (VPI)
Measured: 6 months
Probing pocket depth (PPD)
Change in probing pocket depth (PPD)
Measured: 6 months
Clinical attachment level (CAL)
Change in clinical attachment level (CAL)
Measured: 6 months
Deep periodontal pockets (over 4 mm)
Change in the number of deep periodontal periodontal pockets (over 4 mm)
Measured: 6 months
Periodontal microbiological flora
Change in periodontal microbiological flora during the study period
Measured: 6 months
Additional visits
Number of additional visits due to periodontitis status between 2nd and 3rd follow-up visits
Measured: 6 months
OHIP-14
Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start6 Jun 2023
- Primary completion12 Dec 2025
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Periodontitis Chronic Generalized ModerateStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koite Health Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, Lithuanian University of Health Sciences
- Responsible party
- Sponsor
- Investigators
- Timo Sorsa, Professor, Study director, University of HelsinkiTommi Pätilä, Docent, Study chair, Koite HealthIngrida Marija Pacauskiene, Doctor, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698823
- Sponsor's protocol ID
- LumoKaunas2023
- Status last verified
- Mar 2026
- First submitted
- 16 Jan 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will only be administered by the researchers that are listed in the CIP.
Publications
Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.
PubMed 25261053Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.
PubMed 28792274Lang NP, Suvan JE, Tonetti MS. Risk factor assessment tools for the prevention of periodontitis progression a systematic review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S59-70. doi: 10.1111/jcpe.12350.
PubMed 25496279Nikinmaa 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 34063662Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
PubMed 9332805
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis
- ClinicalTrials.gov ID
- NCT05698823
- Acronym / sponsor ID
- LumoKaunas2023
- Keywords
- Lumoral, Lumorinse, Periodontitis, Anti-bacterial photodynamic therapy, aPDT, Plaque, aMMP-8, Photobiomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Koite Health OyIndustry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, Lithuanian University of Health Sciences
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 26 Jan 2023 (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 study is designed to determine the efficacy of the Lumoral method in chronic periodontitis with a targeted group of stage III and IV periodontitis.
Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term.
In addition, the method might have a photobiomodulation effect on periodontal tissues.
Detailed description
The Lumoral Treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy (aPDT). The device is used by swishing a specially designed mouth rinse that strongly adheres to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown promising anti-inflammatory responses in addition to plaque reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Lumoral TreatmentA complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss. |
| Control group | No intervention | –A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Periodontal disease stage III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss.
- ≥ 18 years old
- Presence of ≥20 teeth, including implants
- Agreement to participate in the study and to sign a written consent form
- Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol
Key exclusion criteria (10 listed)
- Grade A or C periodontitis
- Presence of any physical limitation or restriction that might restrict Lumoral use
- Pregnancy or lactation
- Active smoking
- Medicated diabetes mellitus (DM)
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 TreatmentThe Lumoral treatment -device is a CE-marked antibacterial home-use device for the treatment and prevention of oral diseases caused by bacteria. It is used in combination with a CE-marked mouth rinse called Lumorinse. | Device | Study group |
Primary outcome
Bleeding on probing (BOP)
Time frame: 6 months
Improvement in bleeding on probing (BOP) * A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) * Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus * Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent" * BOP is reported as the percentage (%) of sites with positive findings * Calculation formula: number of bleeding sites/ 6 times number of teeth
8 secondary outcomes
Active matrix metalloproteinase 8 (aMMP-8)
Time frame: 6 months
Visible plaque index (VPI)
Time frame: 6 months
Probing pocket depth (PPD)
Time frame: 6 months
Clinical attachment level (CAL)
Time frame: 6 months
Deep periodontal pockets (over 4 mm)
Time frame: 6 months
Periodontal microbiological flora
Time frame: 6 months
Additional visits
Time frame: 6 months
OHIP-14
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 25261053Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.
- Background: PubMed 28792274Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.
- Background: PubMed 25496279Lang NP, Suvan JE, Tonetti MS. Risk factor assessment tools for the prevention of periodontitis progression a systematic review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S59-70. doi: 10.1111/jcpe.12350.
- 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 9332805Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
- Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review. Laser Dent Sci 3, 147-153 (2019)Link provided by the sponsor.
- Gomes SC, Romagna R, Rossi V, Corvello PC, Melchiors-Angst PD. Supragingival treatment as an aid to reduce subgingival needs: a 450-day investigation Braz. oral res. 28 (1) 2014Link provided by the sponsor.
- Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.Link provided by the sponsor.
- Nikinmaa S, Alapulli H, Auvinen P, et al. (2020) Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. PLoS ONE 15(5): e0232775Link provided by the sponsor.
- Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease. Parkinsonism and Related Disorders 38: 61-67Link provided by the sponsor.
- Individual participant dataSharing planned: No. The IPD will only be administered by the researchers that are listed in the CIP.
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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.
Timo Sorsa, Professor study director
University of Helsinki
Tommi Pätilä, Docent study chair
Koite Health
Ingrida Marija Pacauskiene, Doctor principal investigator
Lithuanian University of Health 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 Periodontitis Chronic Generalized Moderate and Periodontitis Chronic Generalized Severe, run by Koite Health Oy at 1 site in Lithuania.
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 10 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: finished, as of the sponsor's last update on 19 Mar 2026. 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 Lithuania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bleeding on probing (BOP) (time frame: 6 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 NCT05698823, which also lists 5 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 19 Mar 2026.