PeriodontitisHOPE-CPNCT05278416
Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis
A study testing Lumoral treatment -device and Lumorinse tablets in people with Periodontitis, run by Koite Health Oy at 1 site in Finland.
Trial summary
The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Lumoral treatment -device and Lumorinse tablets
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteFinland
- Study dates
- 8 Feb 2022to 29 Apr 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
- Healthy volunteers accepted
- 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
- Agreement to participate in the study and to sign a written consent form
Who cannot join
- Untreated/uncontrollable diabetes mellitus (DM) with HbA1c >7%, and HbA1c > 8 if insulin treated DM
- Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
- Use of medicine that would affect the periodontal tissue within the last 6 months (antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers, including doxycycline, bisphosphonates and chlorhexidine)
- Periodontal treatment during the previous 3 months
- Allergic to the photosensitizer
- Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
Show all 10Show fewer
- Removable major prosthesis or major orthodontic appliance
- Active smoking, or habitual use of smokeless tobacco products
- Pregnancy or lactation
- 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.
About this study
Official title: Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis.
The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients.
Read the detailed description
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. The device is used by swishing a mouth rinse, strongly adhering to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in long-term use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
This early-stage study is designed to determine the efficacy of the Lumoral method in periodontitis patients. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.
- Conditions
- Periodontitis
- Being tested
- Lumoral treatment -device and Lumorinse tablets
- Keywords
- Lumoral, Lumorinse, Periodontitis, Anti-bacterial photodynamic therapy, aPDT, Plaque, aMMP-8
- 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 treatment -device and Lumorinse tabletsDevice
Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Lumoral treatment -device and Lumorinse tablets | Active comparator | 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 once a day. Receives: Device: Lumoral treatment -device and Lumorinse tablets |
| Standard of Care | No intervention | Subjects will receive oral hygiene instructions for the sonic toothbrushing and the use of interdental cleaning devices. They will not receive an additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing (BOP)
Clinical change concerning bleeding on probing change. 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)
Clinical Attachment Level (CAL)
Observation of clinical attachment level:
A full-mouth assessment, measured at six sites per tooth. Assessed as the distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (mm). To calculate CAL, two measurements are needed:
distance from the gingival margin to the CEJ and PPD; in recession: PPD + gingival margin to the CEJ; in tissue overgrowth: PPD - gingival margin to the CEJ.
Measured: 6 months
Periodontal Pocket Depth (PPD)
A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)
Measured: 6 months
Device-related adverse events
Absence of device-related serious adverse events or any patterns of device-related adverse events graded as moderate
Measured: 6 months
Inflammation marker aMMP-8 measurement
Change in aMMP8-measurement reflecting the reduction in periodontitis grade. The oral rinse fluid sample collection and the aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions.
Measured: 6 months
Visual Plaque Index (VPI)
Assessment of six index teeth, measured at four sites per tooth
Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent" VPI reported as the percentage (%) of sites with plaque Calculation formula: number of sites with plaque/ 4 times number of teeth.
Measured: 6 months
OHIP-14
Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire.
Measured: 6 months
Patient-related objective: PCS questionnaire
Measurements of internal motivation to dental hygiene by Perceived Competence Scale (PCS) questionnaire.
Measured: 6 months
Patient-related objective: OSCA questionnaire
Measurements of internal motivation to dental hygiene by Oral Self-Care Assessment (OSCA) 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 posted14 Mar 2022
- Study start8 Feb 2022
- Primary completion14 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koite Health Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, Metropolia University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Timo Sorsa, Professor, Principal investigator, Univeristy of HelsinkiTommi Pätilä, Docent, Study director, Koite Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278416
- Sponsor's protocol ID
- KHE2021Metro (HOPE-CP)
- Acronym
- HOPE-CP
- Status last verified
- Jan 2026
- First submitted
- 7 Feb 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 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 Periodontitis.
- ClinicalTrials.gov ID
- NCT05278416
- Acronym / sponsor ID
- HOPE-CP / KHE2021Metro (HOPE-CP)
- Conditions
- Periodontitis
- Keywords
- Lumoral, Lumorinse, Periodontitis, Anti-bacterial photodynamic therapy, aPDT, Plaque, aMMP-8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Koite Health OyIndustry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, Metropolia University of Applied Sciences
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 14 Mar 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.
The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients.
Detailed description
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. The device is used by swishing a mouth rinse, strongly adhering to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in long-term use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
This early-stage study is designed to determine the efficacy of the Lumoral method in periodontitis patients. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumoral treatment -device and Lumorinse tablets | Active comparator | Device: Lumoral treatment -device and Lumorinse tabletsSubjects 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 once a day. |
| Standard of Care | No intervention | –Subjects will receive oral hygiene instructions for the sonic toothbrushing and the use of interdental cleaning devices. They will not receive an additional intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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
- Agreement to participate in the study and to sign a written consent form
Key exclusion criteria (10 listed)
- Untreated/uncontrollable diabetes mellitus (DM) with HbA1c >7%, and HbA1c > 8 if insulin treated DM
- Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
- Use of medicine that would affect the periodontal tissue within the last 6 months (antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers, including doxycycline, bisphosphonates and chlorhexidine)
- Periodontal treatment during the previous 3 months
- Allergic to the photosensitizer
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 treatment -device and Lumorinse tabletsSubjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol. | Device | Lumoral treatment -device and Lumorinse tablets |
Primary outcome
Bleeding on Probing (BOP)
Time frame: 6 months
Clinical change concerning bleeding on probing change. 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
Clinical Attachment Level (CAL)
Time frame: 6 months
Periodontal Pocket Depth (PPD)
Time frame: 6 months
Device-related adverse events
Time frame: 6 months
Inflammation marker aMMP-8 measurement
Time frame: 6 months
Visual Plaque Index (VPI)
Time frame: 6 months
OHIP-14
Time frame: 6 months
Patient-related objective: PCS questionnaire
Time frame: 6 months
Patient-related objective: OSCA questionnaire
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 22 Jan 2026.
- 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.
Timo Sorsa, Professor principal investigator
Univeristy of Helsinki
Tommi Pätilä, Docent study director
Koite Health
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 -device and Lumorinse tablets in people with Periodontitis, 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 4 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 22 Jan 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 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?
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?
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 22 Jan 2026.