Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons
NCT Number: NCT06576063
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Plaque|Bleeding of Subgingival Space|Oral Complication
Interventions: DEVICE: Lumoral Treatment|BEHAVIORAL: Standard oral hygiene methods
Sponsor: Koite Health Oy
Collaborators: University of Helsinki
Sex: ALL
Age: OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-06
Locations: SuperSuu, Loviisa, Uusimaa, 07900, Finland|SuperSuu, Sipoo, Uusimaa, 04130, Finland|KotiHammas, Vantaa, Uusimaa, 01600, Finland

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.

Primary Outcome Measures: Bleeding on probing (BOP), 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: Plaque index (RMNPI), 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), A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm), 9 months|Active matrix metalloproteinase 8 (aMMP-8), 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|Oral Bacterial flora, 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), 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, 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, Any suspicion of an adverse event related to the investigational device, the treatment method, or the study protocol., 9 months