Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons

August 5, 2025 updated by: Koite Health Oy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
    • Uusimaa
      • Loviisa, Uusimaa, Finland, 07900
        • Recruiting
        • SuperSuu
        • Contact:
        • Principal Investigator:
          • Harri Niskanen
        • Sub-Investigator:
          • Katja Gustafsson
      • Sipoo, Uusimaa, Finland, 04130
        • Recruiting
        • SuperSuu
        • Contact:
        • Principal Investigator:
          • Harri Niskanen
        • Sub-Investigator:
          • Katja Gustafsson
      • Vantaa, Uusimaa, Finland, 01600
        • Recruiting
        • KotiHammas
        • Contact:
        • Principal Investigator:
          • Harri Niskanen
        • Sub-Investigator:
          • Karim Abdalla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Standard oral hygiene methods and adjuvant use of Lumoral Treatment device
Device: Lumoral Treatment
Home-use of photodynamic antibacterial dual-light device, used with a marker substance (indocyanine green)
Behavioral: 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
Active Comparator: Control group
Standard oral hygiene methods
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index (RMNPI)
Time Frame: 9 months

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
9 months
Periodontal Pocket Depth (PPD)
Time Frame: 9 months
A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)
9 months
Oral Bacterial flora
Time Frame: 9 months

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
9 months
Dryness of Mouth (DOM)
Time Frame: 9 months

Clinical, visual assessment of oral mucosal moisture/dryness:

0 points: Saliva secretion appears normal (saliva serous, runny)

  1. point: Oral mucosa shiny and tight; and/or saliva foamy or mucousy; and or only a little clear saliva at the bottom of mouth
  2. 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
9 months
OHIP-14 questionnaire
Time Frame: 9 months

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).
9 months
Adverse events
Time Frame: 9 months
Any suspicion of an adverse event related to the investigational device, the treatment method, or the study protocol.
9 months
Active matrix metalloproteinase 8 (aMMP-8)
Time Frame: 9 months
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koite Health Oy

Collaborators

University of Helsinki

Investigators

  • Principal Investigator: Timo Sorsa, Professor, University of Helsinki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LumoKoti2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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