Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons
NCT ID: NCT06576063
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
100 participants
INTERVENTIONAL
2025-01-02
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents
NCT05853679
Regular Antibacterial Photodynamic Therapy on Oral Hygiene in the Elderly 24-hour Care
NCT05720104
Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases
NCT06286501
Photodynamic Treatment in the Management of Residual Biofilm - a Crossover Study
NCT06860321
The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment.
NCT07166224
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study group
Standard oral hygiene methods and adjuvant use of Lumoral Treatment device
Lumoral Treatment
Home-use of photodynamic antibacterial dual-light device, used with a marker substance (indocyanine green)
Standard oral hygiene methods
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
Control group
Standard oral hygiene methods
Standard oral hygiene methods
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lumoral Treatment
Home-use of photodynamic antibacterial dual-light device, used with a marker substance (indocyanine green)
Standard oral hygiene methods
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Helsinki
OTHER
Koite Health Oy
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Timo Sorsa, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Helsinki
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SuperSuu
Loviisa, Uusimaa, Finland
SuperSuu
Sipoo, Uusimaa, Finland
KotiHammas
Vantaa, Uusimaa, Finland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Lahteenmaki 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.
Nikinmaa 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.
Saarela 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.
Saarela 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.
Trujiilo 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.
Suominen 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.
Related Links
Access external resources that provide additional context or updates about the study.
Berger, V., Bour, L., Carter, K. et al. A roadmap to using randomization in clinical trials. BMC Med Res Methodol 21, 168 (2021)
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 1991-7902
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).
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LumoKoti2024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.