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

ConditionsDental PlaqueBleeding of Subgingival SpaceOral Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorKoite Health Oy

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lumoral Treatment

    Device

    Home-use of photodynamic antibacterial dual-light device, used with a marker substance (indocyanine green)

  • Standard oral hygiene methods

    Behavioral

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Study groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
9 months

Secondary outcomes

1

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

Time frame
9 months
2

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)

Time frame
9 months
3

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.

Time frame
9 months
4

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

Time frame
9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Koite Health Oy

Lead sponsor

University of Helsinki

Collaborator

Source ClinicalTrials.gov
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