Clinical trial NCT06576063: Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Plaque
Bleeding of Subgingival Space
Oral Complication
Keywords: Lumoral
Preventive oral care
Antibacterial photodynamic therapy (aBPT)
aMMP-8
Plaque control
Oral hygiene
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: University of Helsinki
First posted: 2024-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical study on a medical device.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bleeding on probing (BOP)
timeFrame: 9 months
Secondary outcomes:
measure: Plaque index (RMNPI)
timeFrame: 9 months
measure: Periodontal Pocket Depth (PPD)
timeFrame: 9 months
measure: Active matrix metalloproteinase 8 (aMMP-8)
timeFrame: 9 months
measure: Oral Bacterial flora
timeFrame: 9 months
measure: Dryness of Mouth (DOM)
timeFrame: 9 months
measure: OHIP-14 questionnaire
timeFrame: 9 months
measure: Adverse events
timeFrame: 9 months
Other outcomes:
Locations:
city: Loviisa
country: Finland
facility: SuperSuu
state: Uusimaa
city: Sipoo
country: Finland
facility: SuperSuu
state: Uusimaa
city: Vantaa
country: Finland
facility: KotiHammas
state: Uusimaa
Study officials:
affiliation: University of Helsinki
name: Timo Sorsa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.