Dental PlaqueNCT06576063
Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons
A study testing Lumoral Treatment and Standard oral hygiene methods in people with Dental Plaque and Bleeding of Subgingival Space, run by Koite Health Oy at 3 sites in Finland.
Trial summary
On average, the dental condition of elderly people is poor due to various reasons. The importance of oral health maintenance of the ageing population has been recognized by the World Health Organization (WHO), as oral health plays a key role in reaching the global goal of the "Decade of Healthy Ageing 2021-2030". Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Bleeding of Subgingival Space, Oral Complication
- What is being tested?
- Lumoral Treatment and Standard oral hygiene methods
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFinland
- Study dates
- 2 Jan 2025to Jun 2027
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- An elderly (age ≥ 65 years) person living at home or at care home, with a possibility to regular dental care appointments
- Ability to understand and sign the informed consent
- At least 10 teeth in the mouth, including implants
- Ability to understand and follow the study protocol, including tooth brushing and following the instructions for the use of Lumoral Treatment, based on the assessment of the investigator
Who cannot join
- Uncontrolled diabetes mellitus (DM)
- Severe dementia or other similar conditions that may restrict understanding of the study information and protocol
- Presence of any physical limitation or restriction that might restrict Lumoral use
- Active smoking and use of other tobacco products
- Use of antibiotics within 4 weeks week prior study
- Oral thrush
- Known sensitivity to near-infrared or antibacterial blue light.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland3 sites, 3 recruiting
- Recruiting
SuperSuu
Loviisa, Uusimaa, 07900
Mikko Kylmänen, 358407245934, mikko.kylmanen@koitehealth.com
Harri Niskanen
- Recruiting
SuperSuu
Sipoo, Uusimaa, 04130
Mikko Kylmänen, +358407245934, mikko.kylmanen@koitehealth.com
Harri Niskanen
- Recruiting
KotiHammas
Vantaa, Uusimaa, 01600
Mikko Kylmänen, +358407245934, mikko.kylmanen@koitehealth.com
Harri Niskanen
About this study
Official title: Effects of the Regular Use of Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons Living at Home or at Care Homes
On average, the dental condition of elderly people is poor due to various reasons. The importance of oral health maintenance of the ageing population has been recognized by the World Health Organization (WHO), as oral health plays a key role in reaching the global goal of the "Decade of Healthy Ageing 2021-2030".
New measures for maintaining good oral health are welcome. The use of antibacterial photodynamic therapy (aPDT) and antibacterial blue light (aBL) has been studied and found to reduce the amount of plaque in the mouth. The Lumoral device is a CE-marked home medical device combining aPDT and aBL, and it is effective in reducing the development of plaque and harmful bacteria in the plaque. The device has also been shown to be easy and safe to use. In this study, a combination of regular dental appointments with the importance of enhanced dental self-care, will be tested as one regional solution for reaching the global goal set by WHO.
Read the detailed description
The ageing population is increasing rapidly worldwide. In the year 2000, there were 69 million people over the age of 80 in the world, and it is estimated that by the year 2030, 1 out of 6 persons will be 60 years of age or more worldwide. The proportion of the ageing population having their natural teeth left is also increasing. In Finland, the average number of toothless people aged over 65 has decreased from 44% measured in the year 2000 to 21% in 2011.
As people get older, their ability to function deteriorates, and the elderly, especially those living in round-the-clock care, have been found to have shortcomings in maintaining oral hygiene. Toothlessness is reduced in the elderly population living in care homes, too. According to a Study in Finland, in 2003, 52 % of inhabitants were toothless in enhanced service housing, and in 2017, the proportion of toothless had decreased to 38%. In 2017-2018, inhabitants of elderly care homes had an average of 13.8 teeth. Only a small proportion of the population had clean teeth, and the worse the level of oral hygiene, the worse the quality of life.
The World Health Organization has proposed a "Decade of Healthy Ageing 2021-2030" action plan to encourage countries to develop and implement policies and programs to promote healthy ageing and improve the quality of life in the older population. While there is an interrelation between oral and systemic health, periodontal health has been linked to several chronic systemic conditions such as diabetes and cardiovascular diseases via shared inflammatory pathways. Good oral health enables daily functions like eating and speaking, while tooth loss, hyposalivation and other oral conditions obstruct oral functions and make nutritional intake more difficult. Bad oral condition also affects social interaction and quality of life. As oral functioning declines, it is associated with a decline in general function and weakness in the older population, and it can eventually lead even to disability and loss of independence. Therefore, the World Health Organization together with the World Dental Federation have recognized the importance of oral health maintenance and functioning to enable healthy ageing in older adults.
The dental condition of elderly persons is often poor. Cavities and dental connective tissue disease are relatively common in persons of 75 and older. Untreated oral infections predispose elderly people to pneumonia, among other complications. Chronic oral infectious diseases, and sometimes fatal complications, are preventable with good oral hygiene. Regular cleaning of the mouth and teeth from plaque is still the most important thing for keeping the mouth healthy. One third of the aged population in Finland suffers from dry mouth due to various illnesses or the use of many medications. Lack or reduction of saliva may predispose to inflammatory diseases in the mouth. If multiple medications are in use simultaneously, the dry mouth symptoms may even worsen.
The use of antibacterial photodynamic therapy (aPDT) and antibacterial blue light, as adjunctive treatments to standard oral home care has been studied and found to reduce the amount of plaque in the mouth. The Lumoral device is a CE class IIa -marked medical device for home use that has been found to be effective in reducing the development of plaque and harmful bacteria in the plaque. The performance of the device is based on the aPDT method, in which the photosensitive substance in the Lumorinse mouthwash attaches to the bacterial coating and is activated as an antibacterial by light. The antibacterial effect is applied directly to the plaque, reducing the impact on the normal oral flora. Preliminary studies have found that the method reduces inflammatory factors in periodontitis. In addition, the heat produced by the device also enhances saliva production, which also affects maintaining good oral health. Unpublished data from a randomized clinical trial conducted by the University of Helsinki in which Lumoral was used by the residents of elderly 24-hour care also showed that the device was safe to use, and it had a significant impact on oral health measured by the Community Periodontal Index.
This study aims to determine the effectiveness of the Lumoral Treatment method as an adjunctive treatment on oral hygiene, inflammatory load, and dryness of mouth in elderly people living at home or at care homes, and who are regular customers with the study sites.
- Being tested
- Lumoral Treatment, Standard oral hygiene methods
- Keywords
- Lumoral, Preventive oral care, Antibacterial photodynamic therapy (aBPT), aMMP-8, Plaque control, Oral hygiene
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumoral TreatmentDevice
Home-use of photodynamic antibacterial dual-light device, used with a marker substance (indocyanine green)
Standard oral hygiene methodsBehavioural
Best available standard oral self-care hygiene methods performed at home and instructed by oral healthcare professionals, supported by professional cleaning at the oral healthcare clinic
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Standard oral hygiene methods and adjuvant use of Lumoral Treatment device Receives: Device: Lumoral Treatment; Behavioral: Standard oral hygiene methods |
| Control group | Active comparator | Standard oral hygiene methods Receives: Behavioral: Standard oral hygiene methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing (BOP)
Change in the inflammatory parameter 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: 9 months
Secondary outcomes (7)
Plaque index (RMNPI)
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"
- RMNPI reported as the percentage (%) of sites with plaque
- Calculation formula: number of sites with plaque/ 4 times number of teeth
Measured: 9 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: 9 months
Active matrix metalloproteinase 8 (aMMP-8)
Change in periodontal inflammation marker aMMP-8. 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: 9 months
Oral Bacterial flora
Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis
- Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis
Measured: 9 months
Dryness of Mouth (DOM)
Clinical, visual assessment of oral mucosal moisture/dryness:
0 points: Saliva secretion appears normal (saliva serous, runny)
- point: Oral mucosa shiny and tight; and/or saliva foamy or mucousy; and or only a little clear saliva at the bottom of mouth
- points: Mouth completely dry, mirror sticks to cheek or tongue, mucous membranes often reddened; and/or knuckles on the surface of the tongue have disappeared; and/or mouth appears carstic
Measured: 9 months
OHIP-14 questionnaire
Measures people's perception of the social impact of oral disorders on their well-being.
Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Responses are made on a 5-point scale (from 0 = never, to 4 = very often).
Measured: 9 months
Adverse events
Any suspicion of an adverse event related to the investigational device, the treatment method, or the study protocol.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start2 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (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 Dental PlaqueStudies 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
- Randomized clinical study on a medical device.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koite Health Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Timo Sorsa, Professor, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576063
- Sponsor's protocol ID
- LumoKoti2024
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cugini M, Thompson M, Warren PR. Correlations between two plaque indices in assessment of toothbrush effectiveness. J Contemp Dent Pract. 2006 Nov 1;7(5):1-9.
PubMed 17091134Lahteenmaki 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 35723308Nikinmaa 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 34063662Saarela RKT, Hiltunen K, Mantyla P, Pitkala KH. Changes in Institutionalized Older People's Dentition Status in Helsinki, 2003-2017. J Am Geriatr Soc. 2020 Jan;68(1):221-223. doi: 10.1111/jgs.16230. Epub 2019 Oct 26. No abstract available.
PubMed 31654530Saarela RKT, Hiltunen K, Kautiainen H, Roitto HM, Mantyla P, Pitkala KH. Oral hygiene and health-related quality of life in institutionalized older people. Eur Geriatr Med. 2022 Feb;13(1):213-220. doi: 10.1007/s41999-021-00547-8. Epub 2021 Jul 27.
PubMed 34313976Trujiilo K, Raisanen IT, Sorsa T, Patila T. Repeated Daily Use of Dual-Light Antibacterial Photodynamic Therapy in Periodontal Disease-A Case Report. Dent J (Basel). 2022 Sep 1;10(9):163. doi: 10.3390/dj10090163.
PubMed 36135158Suominen AL, Varsio S, Helminen S, Nordblad A, Lahti S, Knuuttila M. Dental and periodontal health in Finnish adults in 2000 and 2011. Acta Odontol Scand. 2018 Jul;76(5):305-313. doi: 10.1080/00016357.2018.1451653. Epub 2018 Mar 16.
PubMed 29546776
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Regular Use of Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons Living at Home or at Care Homes
- ClinicalTrials.gov ID
- NCT06576063
- Acronym / sponsor ID
- LumoKoti2024
- Keywords
- Lumoral, Preventive oral care, Antibacterial photodynamic therapy (aBPT), aMMP-8, Plaque control, Oral hygiene
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Koite Health OyIndustry (pharma, biotech, devices)
- Collaborators
- University of Helsinki
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Aug 2024 (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.
On average, the dental condition of elderly people is poor due to various reasons. The importance of oral health maintenance of the ageing population has been recognized by the World Health Organization (WHO), as oral health plays a key role in reaching the global goal of the "Decade of Healthy Ageing 2021-2030".
New measures for maintaining good oral health are welcome. The use of antibacterial photodynamic therapy (aPDT) and antibacterial blue light (aBL) has been studied and found to reduce the amount of plaque in the mouth. The Lumoral device is a CE-marked home medical device combining aPDT and aBL, and it is effective in reducing the development of plaque and harmful bacteria in the plaque. The device has also been shown to be easy and safe to use. In this study, a combination of regular dental appointments with the importance of enhanced dental self-care, will be tested as one regional solution for reaching the global goal set by WHO.
Detailed description
The ageing population is increasing rapidly worldwide. In the year 2000, there were 69 million people over the age of 80 in the world, and it is estimated that by the year 2030, 1 out of 6 persons will be 60 years of age or more worldwide. The proportion of the ageing population having their natural teeth left is also increasing. In Finland, the average number of toothless people aged over 65 has decreased from 44% measured in the year 2000 to 21% in 2011.
As people get older, their ability to function deteriorates, and the elderly, especially those living in round-the-clock care, have been found to have shortcomings in maintaining oral hygiene. Toothlessness is reduced in the elderly population living in care homes, too. According to a Study in Finland, in 2003, 52 % of inhabitants were toothless in enhanced service housing, and in 2017, the proportion of toothless had decreased to 38%. In 2017-2018, inhabitants of elderly care homes had an average of 13.8 teeth. Only a small proportion of the population had clean teeth, and the worse the level of oral hygiene, the worse the quality of life.
The World Health Organization has proposed a "Decade of Healthy Ageing 2021-2030" action plan to encourage countries to develop and implement policies and programs to promote healthy ageing and improve the quality of life in the older population. While there is an interrelation between oral and systemic health, periodontal health has been linked to several chronic systemic conditions such as diabetes and cardiovascular diseases via shared inflammatory pathways. Good oral health enables daily functions like eating and speaking, while tooth loss, hyposalivation and other oral conditions obstruct oral functions and make nutritional intake more difficult. Bad oral condition also affects social interaction and quality of life. As oral functioning declines, it is associated with a decline in general function and weakness in the older population, and it can eventually lead even to disability and loss of independence. Therefore, the World Health Organization together with the World Dental Federation have recognized the importance of oral health maintenance and functioning to enable healthy ageing in older adults.
The dental condition of elderly persons is often poor. Cavities and dental connective tissue disease are relatively common in persons of 75 and older. Untreated oral infections predispose elderly people to pneumonia, among other complications. Chronic oral infectious diseases, and sometimes fatal complications, are preventable with good oral hygiene. Regular cleaning of the mouth and teeth from plaque is still the most important thing for keeping the mouth healthy. One third of the aged population in Finland suffers from dry mouth due to various illnesses or the use of many medications. Lack or reduction of saliva may predispose to inflammatory diseases in the mouth. If multiple medications are in use simultaneously, the dry mouth symptoms may even worsen.
The use of antibacterial photodynamic therapy (aPDT) and antibacterial blue light, as adjunctive treatments to standard oral home care has been studied and found to reduce the amount of plaque in the mouth. The Lumoral device is a CE class IIa -marked medical device for home use that has been found to be effective in reducing the development of plaque and harmful bacteria in the plaque. The performance of the device is based on the aPDT method, in which the photosensitive substance in the Lumorinse mouthwash attaches to the bacterial coating and is activated as an antibacterial by light. The antibacterial effect is applied directly to the plaque, reducing the impact on the normal oral flora. Preliminary studies have found that the method reduces inflammatory factors in periodontitis. In addition, the heat produced by the device also enhances saliva production, which also affects maintaining good oral health. Unpublished data from a randomized clinical trial conducted by the University of Helsinki in which Lumoral was used by the residents of elderly 24-hour care also showed that the device was safe to use, and it had a significant impact on oral health measured by the Community Periodontal Index.
This study aims to determine the effectiveness of the Lumoral Treatment method as an adjunctive treatment on oral hygiene, inflammatory load, and dryness of mouth in elderly people living at home or at care homes, and who are regular customers with the study sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical study on a medical device.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Lumoral Treatment, Behavioral: Standard oral hygiene methodsStandard oral hygiene methods and adjuvant use of Lumoral Treatment device |
| Control group | Active comparator | Behavioral: Standard oral hygiene methodsStandard oral hygiene methods |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- An elderly (age ≥ 65 years) person living at home or at care home, with a possibility to regular dental care appointments
- Ability to understand and sign the informed consent
- At least 10 teeth in the mouth, including implants
- Ability to understand and follow the study protocol, including tooth brushing and following the instructions for the use of Lumoral Treatment, based on the assessment of the investigator
Key exclusion criteria (7 listed)
- Uncontrolled diabetes mellitus (DM)
- Severe dementia or other similar conditions that may restrict understanding of the study information and protocol
- Presence of any physical limitation or restriction that might restrict Lumoral use
- Active smoking and use of other tobacco products
- Use of antibiotics within 4 weeks week prior study
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 TreatmentHome-use of photodynamic antibacterial dual-light device, used with a marker substance (indocyanine green) | Device | Study group |
| Standard oral hygiene methodsBest available standard oral self-care hygiene methods performed at home and instructed by oral healthcare professionals, supported by professional cleaning at the oral healthcare clinic | Behavioural | Control group, Study group |
Primary outcome
Bleeding on probing (BOP)
Time frame: 9 months
Change in the inflammatory parameter 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.
7 secondary outcomes
Plaque index (RMNPI)
Time frame: 9 months
Periodontal Pocket Depth (PPD)
Time frame: 9 months
Active matrix metalloproteinase 8 (aMMP-8)
Time frame: 9 months
Oral Bacterial flora
Time frame: 9 months
Dryness of Mouth (DOM)
Time frame: 9 months
OHIP-14 questionnaire
Time frame: 9 months
Adverse events
Time frame: 9 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 7 Aug 2025.
- Background: PubMed 17091134Cugini M, Thompson M, Warren PR. Correlations between two plaque indices in assessment of toothbrush effectiveness. J Contemp Dent Pract. 2006 Nov 1;7(5):1-9.
- 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 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 31654530Saarela RKT, Hiltunen K, Mantyla P, Pitkala KH. Changes in Institutionalized Older People's Dentition Status in Helsinki, 2003-2017. J Am Geriatr Soc. 2020 Jan;68(1):221-223. doi: 10.1111/jgs.16230. Epub 2019 Oct 26. No abstract available.
- Background: PubMed 34313976Saarela RKT, Hiltunen K, Kautiainen H, Roitto HM, Mantyla P, Pitkala KH. Oral hygiene and health-related quality of life in institutionalized older people. Eur Geriatr Med. 2022 Feb;13(1):213-220. doi: 10.1007/s41999-021-00547-8. Epub 2021 Jul 27.
- Background: PubMed 36135158Trujiilo K, Raisanen IT, Sorsa T, Patila T. Repeated Daily Use of Dual-Light Antibacterial Photodynamic Therapy in Periodontal Disease-A Case Report. Dent J (Basel). 2022 Sep 1;10(9):163. doi: 10.3390/dj10090163.
- Background: PubMed 29546776Suominen AL, Varsio S, Helminen S, Nordblad A, Lahti S, Knuuttila M. Dental and periodontal health in Finnish adults in 2000 and 2011. Acta Odontol Scand. 2018 Jul;76(5):305-313. doi: 10.1080/00016357.2018.1451653. Epub 2018 Mar 16.
- Berger, V., Bour, L., Carter, K. et al. A roadmap to using randomization in clinical trials. BMC Med Res Methodol 21, 168 (2021)Link provided by the sponsor.
- Chan, AKY., Chu, CH., Ogawa, H., Hsiang-Hua Lai, E. Improving oral health of older adults for healthy ageing, Journal of Dental Sciences. (2023). ISSN 1991-7902Link provided by the sponsor.
- Dodds, M., Roland, S., Edgar, M. et al. Saliva A review of its role in maintaining oral health and preventing dental disease. BDJ Team 2, 15123 (2015).Link provided by the sponsor.
- Pakarinen, S., Saarela, RKT., Välimaa, H., Heikkinen, AM., Kankuri, E., Noponen, M., Alapulli, H., Tervahartiala, T., Räisänen, IT., Sorsa, T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CPLink 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.
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 methods in people with Dental Plaque and Bleeding of Subgingival Space, 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 4 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: looking for participants now, as of the sponsor's last update on 7 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 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?
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?
Contact Mikko Kylmänen, Master of Health Care (+358407245934, mikko.kylmanen@koitehealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on probing (BOP) (time frame: 9 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 NCT06576063, 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 7 Aug 2025.