Regular Antibacterial Photodynamic Therapy on Oral Hygiene in the Elderly 24-hour Care

Koite Health

Status: Withdrawn

Conditions: Dryness Oral; Plaque; Inflamed Gums

Treatments: Device: Lumoral Treatment; Other: Standard oral hygiene instructions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05720104

FlexKoi2022

Details and patient eligibility

About

This study aims to determine the effectiveness of the Lumoral device on oral hygiene, inflammatory load, and dryness of mouth in elderly 24-hour care residents. The second aim is to investigate the usefulness and benefits of the aMMP-8 chair-side test and the Lumoral device in improving the oral hygiene of elderly people. In addition, the study will investigate the usability of Lumoral assessed by different care professionals to evaluate the need for oral care and plaque control procedures in elderly residents.

Full description

The dental condition of elderly care customers is often poor. Cavities and dental connective tissue disease are widespread in people over 75 and older. Untreated oral infections in patients or residents living in institutional care predispose to pneumonia, among other complications. Chronic oral infectious diseases, and sometimes fatal complications, are preventable with good oral hygiene.

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. Only a small part of the population had clean teeth, and the worse the level of oral hygiene, the worse the quality of life. Regular cleaning of the mouth and teeth from plaque is still the most important thing for keeping your mouth healthy. Unfortunately, this is not always the case with round-the-clock care, and new practices are needed to improve oral hygiene.

The use of antibacterial photodynamic therapy (aPDT) and antibacterial blue light has been studied and found to reduce the amount of plaque in the mouth. The Lumoral device is a CE-marked home medical device that has been shown 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A 24-hour care resident;
• Understand and able to give consent to the study;
• At least 10 functional teeth in the mouth (including implants);
• Able to brush teeth and follow the instruction for use Lumoral treatment, based on the assessment by the nursing staff.

Exclusion criteria

• Incapable of participating in the study based on the assessment of the nursing staff
• Toothless or less than 10 functional teeth in the mouth (including implants)
• Unwilling or unable to give consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Study group

Experimental group

Description:

Use of Lumoral Treatment device. Standard oral hygiene instructions.

Treatment:

Other: Standard oral hygiene instructions

Device: Lumoral Treatment

Control group

Other group

Description:

Standard oral hygiene instructions.

Treatment:

Other: Standard oral hygiene instructions