Healthy AdultsNCT06860321
Photodynamic Treatment in the Management of Residual Biofilm - a Crossover Study
A study testing Adjunct antibacterial home-use dual-light medical device and Regular oral self care in people with Healthy Adults and Plaque, Dental, run by Koite Health Oy at 1 site in Finland.
Trial summary
This research introduces a home-use dual-light antibacterial medical device and its possible added value as part of traditional dental self-care. The aim of the study is to investigate, using a randomized cross-over study design, whether home-use dual-light antibacterial treatment is more effective in reducing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Plaque, Dental
- What is being tested?
- Adjunct antibacterial home-use dual-light medical device and Regular oral 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
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 29 Mar 2025to 9 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent voluntarily
- Good general health
Who cannot join
- Periodontitis
- Inability to perform regular oral self-care
Trial locations and contacts
1 site in 1 country.
About this study
This research introduces a home-use dual-light antibacterial medical device and its possible added value as part of traditional dental self-care. The aim of the study is to investigate, using a randomized cross-over study design, whether home-use dual-light antibacterial treatment is more effective in reducing residual biofilm than mechanical, traditional cleaning of teeth and interdental spaces.
Read the detailed description
The antimicrobial effect of aPDT is based on the principle that light as such activates a non-toxic, photosensitive molecule, generating reactive oxygen species that kill the bacterium. Applications of aPDT in dentistry include the treatment of bacterial and fungal infections and the diagnosis of lesions. In dental treatment, regular photodynamic treatment with dual-light has been shown to be beneficial for the gingival health of dental implants and to reduce the amount of visible plaque (VPI). Photodynamic treatment has also been shown to slow down the amount of biofilm re-forming in the mouth.
The simultaneous use of blue light and near-infrared light operating at 810 nm and 405 nm has been shown to reduce Staphylococcus aureus more effectively than using only a single light source. The use of indocyanine green as a photosensitizer in dual-light phototherapy has also been shown to be effective in eliminating Streptococcus oralis. Indocyanine green has otherwise low toxicity to dental restorative materials and to non-target host tissue. Indocyanine green is also very suitable as a photosensitizer due to its high absorption peak. Indocyanine green-mediated photodynamic therapy as an adjunct to non-surgical periodontal treatment has been shown to improve treatment outcomes for dental adhesive tissue diseases with statistically significant results at 3 months and 6 months after treatment with periodontitis patients. There is in vitro evidence for the efficacy of indocyanine green specifically against periodontal pathogens.
Tooth decay, gingivitis and periodontitis are common oral infections associated with tooth extraction and are caused by bacteria living in the mouth. In total, more than 500 different species of bacteria can be found in the mouth. The normal flora of a healthy mouth is rich in a variety of microbes that start to multiply from birth.
Bacteria of different species form biofilms, or plaques (bacterial communities), on the tooth surfaces, some of which mutate to become pro-inflammatory. Most oral diseases are multifactorial. A high-sugar diet, poor oral hygiene, general diseases, dry mouth, ill-fitting dentures or antimicrobial therapy can affect the microbial balance in the mouth and thus contribute to the development of oral diseases. Locally, oral areas are affected by possible plaque overgrowth, orthodontic appliances, open caries deposits and partially erupted wisdom teeth, which provide an easy attachment site for bacterial pathogens and a challenging area to clean.
As biofilm accumulates at the gum line over several days, it causes the tissue to release inflammatory neurotransmitters that call on defense cells from the bloodstream to destroy bacteria. Inflammation of the gums appears as swelling, redness and bleeding on cleaning. If gingivitis becomes chronic, it is a risk for periodontitis, which is the inflammation and tissue destruction of the attachment tissues. Periodontitis is manifested in the mouth as inflammation of the attachment tissues, with deepening of the gum pockets around the tooth, increased tooth mobility, and alveolar leakage on X-rays.
Careful, daily self-care and regular dental hygiene are the most important preventive measures for oral and jaw infections and dental infections. The surface of the tooth does not clean itself like the surface of the mucous membrane or skin through natural taming, so it must be cleaned mechanically. It is recommended to brush the teeth twice a day for two minutes with fluoride toothpaste and to brush the interdental spaces every 24 hours with a suitable instrument.
Lumoral® is a powerful LED light device with a mouthpiece operating blue light at 405 nm and near-infrared light at 810 nm. The Lumoral® treatment involves a combination of the use of mouth rinse inculding indocyanine green , Lumorinse®, and the Lumoral® dual-light mouthpiece. A tablet of Lumorinse® is dissolved in 30 millilitres of water to form a mouthwash, which is swished around the oral cavity for 60 seconds. After using the mouthwash, the Lu-moral® mouthpiece is placed in the mouth for 10 minutes of light activation. After use, the teeth are cleaned by brushing and cleaning the interdental spaces.
The active photosensitive substance of Lumorinse® adheres to the surface of the dental plaque, and the targeted light from the mouthpiece produces an antibacterial effect in the mouth. Lumoral® does not cause bacterial resistance, making it suitable for regular use. The treatment is bacterio-selective, meaning that it targets only harmful microbes in the mouth and does not affect the normal oral flora.
The purpose of this study is to investigate the amount of residual biofilm by comparing conventional tooth cleaning with the additional cleaning of teeth with Lumoral®. The aim is to determine whether Lumoral® treatment reduces the amount of residual biofilm in the mouth in adults in general good oral health.
- Conditions
- Healthy Adults, Plaque, Dental
- Being tested
- Adjunct antibacterial home-use dual-light medical device, Regular oral self care
- Keywords
- aPDT, photodynamic treatment, plaque control
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunct antibacterial home-use dual-light medical deviceDevice
Crossover active intervention.
Regular oral self careOther
Crossover regular intervention.
| Study group | Role | What they receive |
|---|---|---|
| Group A day 1, and Group B day 2 | Active comparator | 1) and 2) Electric toothbrushing and flossing, plaque staining and dental scan performed twice. Receives: Other: Regular oral self care |
| Group A day 2, and Group B day 1 | Experimental | 1. One minute of Lumorinse mouth rinse swishing followed by 10 minutes of Lumoral device use, followed by electric toothbrushing and flossing.
2. Electric toothbrushing and flossing, plaque staining and dental scan performed twice. Receives: Device: Adjunct antibacterial home-use dual-light medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rustogi plaque index
The index divides the outer or inner surface of the tooth into 9 parts, based on which the amount of plaque is scored. Each tooth can score a maximum of 18 points and a minimum of 0 points at the analysis stage. The more points, the more plaque on the tooth surface is recorded
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start29 Mar 2025
- Primary completion8 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects are randomly divided into two group A and B. Data will be collected in two non-consecutive days to allow time for biofilm to re-form in the mouth. On study day 1, in both groups, teeth are cleaned at the study site by the participants themselves with an electric toothbrush and appropriate interdental cleaning tools, followed by plaque staining. The teeth are then scanned thoroughly with an oral scanner. Group A participants will perform a second dental cleaning themselves with an electric toothbrush and appropriate interdental cleaning tools, followed by plaque staining and scanning. Group B participants will perform a second dental cleaning themselves with Lumoral according to manufacture's instructions, followed by cleaning themselves with an electric toothbrush and appropriate interdental cleaning tools, followed by plaque staining and scanning. On study day 2, groups A and B will swap places and perform the same procedures as the other group on study day 1.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koite Health Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Metropolia University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Mikko Kylmänen, Master of Health Care, Study director, Koite Health OySaila Pakarinen, Master of Arts in Education, Principal investigator, Metropolia University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860321
- Sponsor's protocol ID
- PhoBCo
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bashir NZ, Singh HA, Virdee SS. Indocyanine green-mediated antimicrobial photodynamic therapy as an adjunct to periodontal therapy: a systematic review and meta-analysis. Clin Oral Investig. 2021 Oct;25(10):5699-5710. doi: 10.1007/s00784-021-03871-2. Epub 2021 Mar 12.
PubMed 33710461Cieplik F, Deng D, Crielaard W, Buchalla W, Hellwig E, Al-Ahmad A, Maisch T. Antimicrobial photodynamic therapy - what we know and what we don't. Crit Rev Microbiol. 2018 Sep;44(5):571-589. doi: 10.1080/1040841X.2018.1467876. Epub 2018 May 11.
PubMed 29749263Huang YY, Sharma SK, Carroll J, Hamblin MR. Biphasic dose response in low level light therapy - an update. Dose Response. 2011;9(4):602-18. doi: 10.2203/dose-response.11-009.Hamblin. Epub 2011 Sep 2.
PubMed 22461763Karu T. Primary and secondary mechanisms of action of visible to near-IR radiation on cells. J Photochem Photobiol B. 1999 Mar;49(1):1-17. doi: 10.1016/S1011-1344(98)00219-X.
PubMed 10365442Kessel D. Photodynamic Therapy: A Brief History. J Clin Med. 2019 Oct 2;8(10):1581. doi: 10.3390/jcm8101581.
PubMed 31581613Lahteenmaki 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 34063662Nikinmaa S, Podonyi A, Raivio P, Meurman J, Sorsa T, Rantala J, Kankuri E, Tauriainen T, Patila T. Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus. Antibiotics (Basel). 2021 Oct 13;10(10):1240. doi: 10.3390/antibiotics10101240.
PubMed 34680821Pakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206.
PubMed 36354651Parker S. The use of diffuse laser photonic energy and indocyanine green photosensitiser as an adjunct to periodontal therapy. Br Dent J. 2013 Aug;215(4):167-71. doi: 10.1038/sj.bdj.2013.790.
PubMed 23969654Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9-12.
PubMed 1306676Stajer A, Kajari S, Gajdacs M, Musah-Eroje A, Barath Z. Utility of Photodynamic Therapy in Dentistry: Current Concepts. Dent J (Basel). 2020 May 7;8(2):43. doi: 10.3390/dj8020043.
PubMed 32392793
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
- Photodynamic Treatment in the Management of Residual Biofilm - a Crossover Study
- ClinicalTrials.gov ID
- NCT06860321
- Acronym / sponsor ID
- PhoBCo
- Conditions
- Healthy Adults, Plaque, Dental
- Keywords
- aPDT, photodynamic treatment, plaque control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Koite Health OyIndustry (pharma, biotech, devices)
- Collaborators
- Metropolia University of Applied Sciences
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 6 Mar 2025 (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 research introduces a home-use dual-light antibacterial medical device and its possible added value as part of traditional dental self-care. The aim of the study is to investigate, using a randomized cross-over study design, whether home-use dual-light antibacterial treatment is more effective in reducing residual biofilm than mechanical, traditional cleaning of teeth and interdental spaces.
Detailed description
The antimicrobial effect of aPDT is based on the principle that light as such activates a non-toxic, photosensitive molecule, generating reactive oxygen species that kill the bacterium. Applications of aPDT in dentistry include the treatment of bacterial and fungal infections and the diagnosis of lesions. In dental treatment, regular photodynamic treatment with dual-light has been shown to be beneficial for the gingival health of dental implants and to reduce the amount of visible plaque (VPI). Photodynamic treatment has also been shown to slow down the amount of biofilm re-forming in the mouth.
The simultaneous use of blue light and near-infrared light operating at 810 nm and 405 nm has been shown to reduce Staphylococcus aureus more effectively than using only a single light source. The use of indocyanine green as a photosensitizer in dual-light phototherapy has also been shown to be effective in eliminating Streptococcus oralis. Indocyanine green has otherwise low toxicity to dental restorative materials and to non-target host tissue. Indocyanine green is also very suitable as a photosensitizer due to its high absorption peak. Indocyanine green-mediated photodynamic therapy as an adjunct to non-surgical periodontal treatment has been shown to improve treatment outcomes for dental adhesive tissue diseases with statistically significant results at 3 months and 6 months after treatment with periodontitis patients. There is in vitro evidence for the efficacy of indocyanine green specifically against periodontal pathogens.
Tooth decay, gingivitis and periodontitis are common oral infections associated with tooth extraction and are caused by bacteria living in the mouth. In total, more than 500 different species of bacteria can be found in the mouth. The normal flora of a healthy mouth is rich in a variety of microbes that start to multiply from birth.
Bacteria of different species form biofilms, or plaques (bacterial communities), on the tooth surfaces, some of which mutate to become pro-inflammatory. Most oral diseases are multifactorial. A high-sugar diet, poor oral hygiene, general diseases, dry mouth, ill-fitting dentures or antimicrobial therapy can affect the microbial balance in the mouth and thus contribute to the development of oral diseases. Locally, oral areas are affected by possible plaque overgrowth, orthodontic appliances, open caries deposits and partially erupted wisdom teeth, which provide an easy attachment site for bacterial pathogens and a challenging area to clean.
As biofilm accumulates at the gum line over several days, it causes the tissue to release inflammatory neurotransmitters that call on defense cells from the bloodstream to destroy bacteria. Inflammation of the gums appears as swelling, redness and bleeding on cleaning. If gingivitis becomes chronic, it is a risk for periodontitis, which is the inflammation and tissue destruction of the attachment tissues. Periodontitis is manifested in the mouth as inflammation of the attachment tissues, with deepening of the gum pockets around the tooth, increased tooth mobility, and alveolar leakage on X-rays.
Careful, daily self-care and regular dental hygiene are the most important preventive measures for oral and jaw infections and dental infections. The surface of the tooth does not clean itself like the surface of the mucous membrane or skin through natural taming, so it must be cleaned mechanically. It is recommended to brush the teeth twice a day for two minutes with fluoride toothpaste and to brush the interdental spaces every 24 hours with a suitable instrument.
Lumoral® is a powerful LED light device with a mouthpiece operating blue light at 405 nm and near-infrared light at 810 nm. The Lumoral® treatment involves a combination of the use of mouth rinse inculding indocyanine green , Lumorinse®, and the Lumoral® dual-light mouthpiece. A tablet of Lumorinse® is dissolved in 30 millilitres of water to form a mouthwash, which is swished around the oral cavity for 60 seconds. After using the mouthwash, the Lu-moral® mouthpiece is placed in the mouth for 10 minutes of light activation. After use, the teeth are cleaned by brushing and cleaning the interdental spaces.
The active photosensitive substance of Lumorinse® adheres to the surface of the dental plaque, and the targeted light from the mouthpiece produces an antibacterial effect in the mouth. Lumoral® does not cause bacterial resistance, making it suitable for regular use. The treatment is bacterio-selective, meaning that it targets only harmful microbes in the mouth and does not affect the normal oral flora.
The purpose of this study is to investigate the amount of residual biofilm by comparing conventional tooth cleaning with the additional cleaning of teeth with Lumoral®. The aim is to determine whether Lumoral® treatment reduces the amount of residual biofilm in the mouth in adults in general good oral health.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects are randomly divided into two group A and B. Data will be collected in two non-consecutive days to allow time for biofilm to re-form in the mouth. On study day 1, in both groups, teeth are cleaned at the study site by the participants themselves with an electric toothbrush and appropriate interdental cleaning tools, followed by plaque staining. The teeth are then scanned thoroughly with an oral scanner. Group A participants will perform a second dental cleaning themselves with an electric toothbrush and appropriate interdental cleaning tools, followed by plaque staining and scanning. Group B participants will perform a second dental cleaning themselves with Lumoral according to manufacture's instructions, followed by cleaning themselves with an electric toothbrush and appropriate interdental cleaning tools, followed by plaque staining and scanning. On study day 2, groups A and B will swap places and perform the same procedures as the other group on study day 1.
| Arm | Type | Receives |
|---|---|---|
| Group A day 1, and Group B day 2 | Active comparator | Other: Regular oral self care1) and 2) Electric toothbrushing and flossing, plaque staining and dental scan performed twice. |
| Group A day 2, and Group B day 1 | Experimental | Device: Adjunct antibacterial home-use dual-light medical device1. One minute of Lumorinse mouth rinse swishing followed by 10 minutes of Lumoral device use, followed by electric toothbrushing and flossing. 2. Electric toothbrushing and flossing, plaque staining and dental scan performed twice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent voluntarily
- Good general health
Key exclusion criteria (2 listed)
- Periodontitis
- Inability to perform regular oral self-care
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 |
|---|---|---|
| Adjunct antibacterial home-use dual-light medical deviceCrossover active intervention. | Device | Group A day 2, and Group B day 1 |
| Regular oral self careCrossover regular intervention. | Other | Group A day 1, and Group B day 2 |
Primary outcome
Rustogi plaque index
Time frame: 30 minutes
The index divides the outer or inner surface of the tooth into 9 parts, based on which the amount of plaque is scored. Each tooth can score a maximum of 18 points and a minimum of 0 points at the analysis stage. The more points, the more plaque on the tooth surface is recorded
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 33710461Bashir NZ, Singh HA, Virdee SS. Indocyanine green-mediated antimicrobial photodynamic therapy as an adjunct to periodontal therapy: a systematic review and meta-analysis. Clin Oral Investig. 2021 Oct;25(10):5699-5710. doi: 10.1007/s00784-021-03871-2. Epub 2021 Mar 12.
- Background: PubMed 29749263Cieplik F, Deng D, Crielaard W, Buchalla W, Hellwig E, Al-Ahmad A, Maisch T. Antimicrobial photodynamic therapy - what we know and what we don't. Crit Rev Microbiol. 2018 Sep;44(5):571-589. doi: 10.1080/1040841X.2018.1467876. Epub 2018 May 11.
- Background: PubMed 22461763Huang YY, Sharma SK, Carroll J, Hamblin MR. Biphasic dose response in low level light therapy - an update. Dose Response. 2011;9(4):602-18. doi: 10.2203/dose-response.11-009.Hamblin. Epub 2011 Sep 2.
- Background: PubMed 10365442Karu T. Primary and secondary mechanisms of action of visible to near-IR radiation on cells. J Photochem Photobiol B. 1999 Mar;49(1):1-17. doi: 10.1016/S1011-1344(98)00219-X.
- Background: PubMed 31581613Kessel D. Photodynamic Therapy: A Brief History. J Clin Med. 2019 Oct 2;8(10):1581. doi: 10.3390/jcm8101581.
- 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 34680821Nikinmaa S, Podonyi A, Raivio P, Meurman J, Sorsa T, Rantala J, Kankuri E, Tauriainen T, Patila T. Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus. Antibiotics (Basel). 2021 Oct 13;10(10):1240. doi: 10.3390/antibiotics10101240.
- Background: PubMed 36354651Pakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206.
- Background: PubMed 23969654Parker S. The use of diffuse laser photonic energy and indocyanine green photosensitiser as an adjunct to periodontal therapy. Br Dent J. 2013 Aug;215(4):167-71. doi: 10.1038/sj.bdj.2013.790.
- Background: PubMed 1306676Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9-12.
- Background: PubMed 32392793Stajer A, Kajari S, Gajdacs M, Musah-Eroje A, Barath Z. Utility of Photodynamic Therapy in Dentistry: Current Concepts. Dent J (Basel). 2020 May 7;8(2):43. doi: 10.3390/dj8020043.
- Hentilä, J. et al. (2021). Dual-Light Photodynamic Therapy Effectively Eliminates Streptococcus Oralis Biofilms. JoP\&PS 24.Link provided by the sponsor.
- WHO. 2022. Global oral health status report: towards universal health coverage for oral health by 2030. Geneva.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.
Mikko Kylmänen, Master of Health Care study director
Koite Health Oy
Saila Pakarinen, Master of Arts in Education principal investigator
Metropolia University of Applied 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 Adjunct antibacterial home-use dual-light medical device and Regular oral self care in people with Healthy Adults and Plaque, Dental, 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 2 inclusion and 2 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 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?
Rustogi plaque index (time frame: 30 minutes). 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 NCT06860321, which also lists 12 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.