Using light therapy at home to improve dental hygiene: a study on healthy adults
| ISRCTN | ISRCTN86890686 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86890686 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Koite Health Ltd. |
| Funder | Koite Health Ltd. |
- Submission date
- 13/03/2025
- Registration date
- 28/03/2025
- Last edited
- 14/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Toothbrushing, whether with an electric or manual toothbrush, often leaves 35–50% of plaque behind. Regular use of antibacterial photodynamic therapy has emerged as a promising method to enhance oral hygiene at home. This study aims to evaluate the effectiveness of the antibacterial Lumoral® light-activated treatment in reducing dental plaque as part of daily dental care in healthy volunteers.
Who can participate?
Healthy adults who do not have fixed orthodontic appliances, fixed partial dentures, advanced periodontitis, significant pathology in the oral cavity, or restorable caries lesions. Participants should not have used antibiotics within the last month, should not smoke, and should not have had recent professional dental cleaning or participated in other oral health examinations.
What does the study involve?
Participants will be randomly assigned to one of two groups. One group will receive oral hygiene instructions and use Lumoral® as an additional plaque control method twice a week. The other group will receive oral hygiene instructions alone. Dental plaque will be measured at the start and after four weeks using the Rustogi-modified Navy Plaque Index. Researchers who do not know which group participants are in will conduct the measurements.
What are the possible benefits and risks of participating?
Participants may benefit from improved dental hygiene and reduced plaque levels. Risks are minimal but may include mild discomfort from using the Lumoral® device.
Where is the study run from?
Koite Health Ltd. (Finland)
When is the study starting and how long is it expected to run for?
August 2022 to March 2023
Who is funding the study?
The study was performed in collaboration with the Metropolia University of Applied Sciences and Koite Health Ltd.
Koite Health Ltd. provided the investigational devices for the study. No direct financial contributions to the researchers or the study center were made.
Who is the main contact?
Mikko Kylmänen, mikko.kylmanen@koitehealth.com
Contact information
Public
Karaportti 5
Espoo
02610
Finland
| Phone | +358 407245934 |
|---|---|
| mikko.kylmanen@koitehealth.com |
Scientific
Stenbäckinkatu 9
Helsinki
00290
Finland
 ORCID ID |
0000-0003-2219-4689 |
|---|---|
| Phone | +358 440130770 |
| tommi.patila@gmail.com |
Principal investigator
Myllypurontie 1
Helsinki
00790
Finland
| Phone | +358 75167956 |
|---|---|
| pakarinen.saila@metropolia.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Regularly home-applied dual-light photodynamic therapy on dental hygiene- a prospective randomized study in healthy adults |
| Study acronym | SHINE |
| Study objectives | The Lumoral® treatment, when used twice a week as an adjunct to regular oral care, improves oral hygiene in healthy individuals. |
| Ethics approval(s) |
Approved 31/01/2023, The Human Sciences Ethics Committee of the Helsinki Region Universities of Applied Sciences (Myllypurontie 1, Helsinki, 00920, Finland; +358 401937758; eettinen.toimikunta@metropolia.fi), ref: § 8/2023 |
| Health condition(s) or problem(s) studied | Dental plaque |
| Intervention | At baseline and at 4-week follow-up (+/- 1 week), the biofilm of the subjects' mouths is stained using plaque dye, and clinical plaque index measurements is obtained. After the baseline visit, study subjects are given comprehensive oral self-care instructions including mechanical biofilm removal from free tooth surfaces and interdental spaces. Those randomized in the Treatment group are given a Lumoral® Treatment device and thorough verbal and written instructions to perform dual-light aPDT at home in addition to the comprehensive oral self-care instructions. The participants are randomly assigned to the test and control groups using a sealed envelope technique. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lumoral |
| Primary outcome measure(s) |
Dental plaque levels measured using the Rustogi-modified Navy Plaque Index from clinical plaque staining and scoring at Baseline and Week 4 (+/-1 week) |
| Key secondary outcome measure(s) |
Subjective experience of using the Lumoral® Treatment device measured using a structured questionnaire at Week 4 (+/-1 week) |
| Completion date | 31/03/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 15 |
| Total final enrolment | 15 |
| Key inclusion criteria | Subjects had to be from 18 to 70 years’ age and good general health assessed by study participants themselves. |
| Key exclusion criteria | 1. Oral health-related issues, including fixed orthodontic appliances, fixed partial dentures, advanced periodontitis, significant pathology in the oral cavity, or restorable caries lesions. 2. Medication-related issues, including use of antibiotics within one month. 3. Other factors, including smoking, participation in other oral health examinations, and recent professional dental cleaning. |
| Date of first enrolment | 15/02/2023 |
| Date of final enrolment | 03/03/2023 |
Locations
Countries of recruitment
- Finland
Study participating centre
Helsinki
00920
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | No plan to share IPD. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/03/2025: Trial's existence confirmed by The Human Sciences Ethics Committee of the Helsinki Region Universities of Applied Sciences
