Periodontal DiseasesNCT05425784
Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis
A study testing Lumoral treatment and Standard oral hygiene self care in people with Periodontal Diseases and Periodontitis, run by Koite Health Oy at 3 sites in Finland.
Trial summary
This early-stage research is designed to determine the efficacy of the Lumoral method in chronic periodontitis patients. 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
- Periodontal Diseases, Periodontitis, Plaque, Dental
- What is being tested?
- Lumoral treatment and Standard oral hygiene self care
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesFinland
- Study dates
- 19 Jan 2023to 13 Jan 2025
- 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 I-III, according to criteria the American Academy of Periodontology (AAP) with at least 2 mm interdental CAL in the site of greatest loss.
- Age of 18- 85 years
- 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
- Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
- Removable major prosthesis or major orthodontic appliance
- Pregnancy or lactation
- Use of antibiotics within 2 weeks prior the study
- A need for immediate antimicrobial treatment for periodontitis
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Mehiläinen Länsi-Pohja Central Hospital
Kemi, Lapland, 94100
Hammas Hohde Oy
Oulu, Oulun Lääni, 90230
City of Rovaniemi Health Cervices, Oral Health
Rovaniemi, 96100
About this study
Official title: Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis
This early-stage research is designed to determine the efficacy of the Lumoral method in chronic periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.
Read the detailed description
Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque.
The Lumoral 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. The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.
- Being tested
- Lumoral treatment, Standard oral hygiene self care
- Keywords
- Lumoral, Lumorinse, Plaque, Periodontitis, Plaque control, aPDT, aMMP-8
- Medical subject headings
- Periodontal Diseases, Periodontitis, Dental Plaque, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumoral treatmentDevice
Also called Lumorinse mouth rinse
The investigational Lumoral treatment -device provides a constant and repeatable application which can be done at home and is easily available. All subjects in the study group will receive their own Lumoral treatment -device and Lumorinse-mouth rinse tablets for the complete duration of the study.
Standard oral hygiene self careOther
Also called Electric toothbrush provided
Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.
| Study group | Role | What they receive |
|---|---|---|
| Lumoral Treatment (Study group) | Experimental | Subjects will receive detailed instructions for the use of Lumoral treatment -device and Lumorinse -tablets. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol five to seven (5-7) times a week. Regular use shall be defined as frequency of a minimum of twice a week.
Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects. Receives: Device: Lumoral treatment; Other: Standard oral hygiene self care |
| Standard of care (Control group) | Active comparator | Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects. Receives: Other: Standard oral hygiene self care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in dental inflammation
Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 3 months compared to baseline
Measured: 3 months
Reduction in dental inflammation
Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 6 months compared to baseline
Measured: 6 months
Stabilization of the periodontal disease
Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 3 months compared to baseline
Measured: 3 months
Stabilization of the periodontal disease
Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 6 months compared to baseline
Measured: 6 months
Secondary outcomes (10)
Reduction in aMMP-8 measurement
Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 3 months compared to baseline
Measured: 3 months
Reduction in aMMP-8 measurement
Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 6 months compared to baseline
Measured: 6 months
Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status
Clinical improvement of periodontitis measured by probing pocket depth (PPD) at 3 months based on the absolute values of PPD. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
Measured: 3 months
Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status
Clinical improvement of periodontitis measured by probing pocket depth (PPD) at 6 months based on the absolute values of PPD. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
Measured: 6 months
Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status
Clinical improvement of periodontitis measured by clinical attachment level (CAL) at 3 months based on the absolute values of CAL. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
Measured: 3 months
Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status
Clinical improvement of periodontitis measured by clinical attachment level (CAL) at 6 months based on the absolute values of CAL. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
Measured: 6 months
Change in periodontal microbiological pathogens.
Clinical improvement in periodontal microbiological pathogens at 3 months compared to baseline. The microbiological evaluation is the Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis. Microbiological sample will be collected using so called Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points will then be be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis.
Measured: 3 months
Change in periodontal microbiological pathogens.
Clinical improvement in periodontal microbiological pathogens at 6 months compared to baseline. The microbiological evaluation is the Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis. Microbiological sample will be collected using so called Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points will then be be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis.
Measured: 6 months
Improvement in oral-related quality of life.
Patient related objectives: Improvement in oral-related quality of life measurement (OHIP-14) questionnaire at baseline, at 3 months compared to baseline.
Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'.
Measured: 3 months
Improvement in oral-related quality of life.
Patient related objectives: Improvement in oral-related quality of life measurement (OHIP-14) questionnaire at baseline, at 6 months compared to baseline.
Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'.
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 posted21 Jun 2022
- Study start19 Jan 2023
- Primary completion29 Apr 2024
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- Model description
- 90 participants are randomized into two arms: the Lumoral-treatment arm and Control arm.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koite Health Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, University of Oulu
- Responsible party
- Sponsor
- Investigators
- Tommi Pätilä, Docent, Study director, Chief Medical OfficerTimo Sorsa, Professor, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425784
- Sponsor's protocol ID
- LumoNorth2022
- Status last verified
- Feb 2025
- First submitted
- 31 May 2022
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tegelberg P, Ojala M, Ylipalosaari M, Lindroth J, Heikkinen AM, Lahteenmaki H, Pakarinen S, Raisanen IT, Sorsa T, Patila T. A multicenter, controlled, randomized trial of home-applied dual-light photodynamic therapy in stage I to III periodontitis (LumoNorth2022 study). J Periodontol. 2026 May 12. doi: 10.1002/jper.70120. Online ahead of print.
PubMed 42117907
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. 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 Periodontitis
- ClinicalTrials.gov ID
- NCT05425784
- Acronym / sponsor ID
- LumoNorth2022
- Keywords
- Lumoral, Lumorinse, Plaque, Periodontitis, Plaque control, aPDT, aMMP-8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Koite Health OyIndustry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, University of Oulu
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 21 Jun 2022 (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 early-stage research is designed to determine the efficacy of the Lumoral method in chronic periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.
Detailed description
Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque.
The Lumoral 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. The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 90 participants are randomized into two arms: the Lumoral-treatment arm and Control arm.
| Arm | Type | Receives |
|---|---|---|
| Lumoral Treatment (Study group) | Experimental | Device: Lumoral treatment, Other: Standard oral hygiene self careSubjects will receive detailed instructions for the use of Lumoral treatment -device and Lumorinse -tablets. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol five to seven (5-7) times a week. Regular use shall be defined as frequency of a minimum of twice a week. Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects. |
| Standard of care (Control group) | Active comparator | Other: Standard oral hygiene self careStandard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects. |
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 I-III, according to criteria the American Academy of Periodontology (AAP) with at least 2 mm interdental CAL in the site of greatest loss.
- Age of 18- 85 years
- 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 (5 listed)
- Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
- Removable major prosthesis or major orthodontic appliance
- Pregnancy or lactation
- Use of antibiotics within 2 weeks prior the study
- A need for immediate antimicrobial treatment for periodontitis
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 treatmentAlso: Lumorinse mouth rinseThe investigational Lumoral treatment -device provides a constant and repeatable application which can be done at home and is easily available. All subjects in the study group will receive their own Lumoral treatment -device and Lumorinse-mouth rinse tablets for the complete duration of the study. | Device | Lumoral Treatment (Study group) |
| Standard oral hygiene self careAlso: Electric toothbrush providedBoth groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care. | Other | Lumoral Treatment (Study group), Standard of care (Control group) |
Primary outcome
Reduction in dental inflammation
Time frame: 3 months
Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 3 months compared to baseline
Reduction in dental inflammation
Time frame: 6 months
Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 6 months compared to baseline
Stabilization of the periodontal disease
Time frame: 3 months
Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 3 months compared to baseline
Stabilization of the periodontal disease
Time frame: 6 months
Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 6 months compared to baseline
10 secondary outcomes
Reduction in aMMP-8 measurement
Time frame: 3 months
Reduction in aMMP-8 measurement
Time frame: 6 months
Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status
Time frame: 3 months
Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status
Time frame: 6 months
Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status
Time frame: 3 months
Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status
Time frame: 6 months
Change in periodontal microbiological pathogens.
Time frame: 3 months
Change in periodontal microbiological pathogens.
Time frame: 6 months
Improvement in oral-related quality of life.
Time frame: 3 months
Improvement in oral-related quality of life.
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 18 Feb 2025.
- Derived from this study: PubMed 42117907Tegelberg P, Ojala M, Ylipalosaari M, Lindroth J, Heikkinen AM, Lahteenmaki H, Pakarinen S, Raisanen IT, Sorsa T, Patila T. A multicenter, controlled, randomized trial of home-applied dual-light photodynamic therapy in stage I to III periodontitis (LumoNorth2022 study). J Periodontol. 2026 May 12. doi: 10.1002/jper.70120. Online ahead of print.
- Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review.Link provided by the sponsor.
- Joshi K, Baiju CS, Khashu H, Bansal S (2020) Clinical effectiveness of indocyanine green mediated antimicrobial photodynamic therapy as an adjunct to scaling root planing in treatment of chronic periodontitis- A randomized controlled clinical trial.Link provided by the sponsor.
- Kassebaum NJ, Bernabé E, Dahiya M et al., (2014) Global burden of severe periodontitis in 1990- 2010: a systematic review and meta-regression.Link provided by the sponsor.
- Kassebaum NJ, Smith AGC, Bernabé E, et al., (2017) 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, InjuriesLink provided by the sponsor.
- Lang NP, Suvan JE, Tonetti MS (2015) Risk factor assessment tools for the prevention of periodontitis progression a systematic review.Link provided by the sponsor.
- Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.Link 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.
Tommi Pätilä, Docent study director
Chief Medical Officer
Timo Sorsa, Professor principal investigator
University of Helsinki
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumoral treatment and Standard oral hygiene self care in people with Periodontal Diseases and Periodontitis, run by Koite Health Oy at 3 sites 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 5 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 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Reduction in dental inflammation (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT05425784, which also lists 1 linked publication.
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 18 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.