Clinical trial NCT06860321: Photodynamic Treatment in the Management of Residual Biofilm - a Crossover Study
Official title: Photodynamic Treatment in the Management of Residual Biofilm - a Crossover Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Adults
Plaque, Dental
Keywords: aPDT
photodynamic treatment
plaque control
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: Metropolia University of Applied Sciences
First posted: 2025-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent voluntarily
* Good general health

Exclusion Criteria:

* Periodontitis
* Inability to perform regular oral self-care

Primary outcomes:
measure: Rustogi plaque index
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Oral Hammaslääkärit, Helsinki Bulevardi
Study officials:
affiliation: Koite Health Oy
name: Mikko Kylmänen
role: STUDY_DIRECTOR
References:
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