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

October 11, 2024 updated by: Koite Health Oy

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

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 Locations

  • Sweden
      • Stockholm, Sweden, 11224
        • Pilträdets servicehus

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Use of Lumoral Treatment device. Standard oral hygiene instructions.
Device: Lumoral Treatment
Subjects will receive detailed instructions for the use of Lumoral treatment -device. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day for two months and to keep a diary.
Other: Standard oral hygiene instructions
Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.
Other: Control group
Standard oral hygiene instructions.
Other: Standard oral hygiene instructions
Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral hygiene
Time Frame: 2 months
Improvement in oral hygiene / resident experience. The study subject will fill in a questionnaire related to oral hygiene and mouth dryness at baseline and at 2 months.
2 months
Visual Plaque Index (VPI)
Time Frame: 2 months

Change in the Visible plaque index (VPI) is greater in the Study group compared to the Control group.

VPI:

  • A full-mouth assessment at 4 sites per tooth will be made at baseline and at the 2 month follow-up visit
  • VPI is reported as the percentage (%) of sites with positive findings
  • Dichotomous scoring to each site of the tooth as plaque" 1 present" and" 0 absent"
  • Calculation formula: number of plaque sites/ 4 times number of teeth
2 months
Bleeding on Probing (BOP)
Time Frame: 2 months

Change in the Bleeding on Probing (BOP) is greater in the Study group compared to the Control group.

BOP:

  • A full-mouth assessment at 4 sites per tooth
  • Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus
  • BOP reported as the percentage (%) of sites with positive findings
  • Dichotomous scoring to each site of the tooth as bleeding" 1 present" and" 0 absent"
  • Calculation formula: number of bleeding sites/ 4 times number of teeth
2 months
Probing Pocket Depth (PPD)
Time Frame: 2 months

Change in the Probing Pocket Depth (PPD) values is greater in the Study group compared to the Control group.

PPD:

  • A full-mouth assessment, measured at 4 sites per tooth
  • Assessed from the base of the pocket to the gingival margin (mm)
2 months
aMMP-8
Time Frame: 2 months

Change in the active matrix metalloproteinase 8 values is greater in the Study group compared to the Control group.

The aMMP-8 marker analysis will be performed using the Periosafe chair-side test (Dentognostics GmbH) according to the manufacturer's instructions.

Oral rinse samples will be stored for further analysis according to the Swedish Biobanks in Medical Care Act (SFS 2002:297). Further analysis includes aMMP-8 and its regulators by biochemical enzyme/molecule assays, immunoassays, and proteomics analysis.
2 months
Dry mouth
Time Frame: 2 months

Use of the Lumoral Treatment relieves the symptoms of dry mouth, compared to the Control group.

Clinical assessment of moisture/dryness of oral mucosa (score 0-2) 0 = Saliva secretion looks normal (saliva serous and running)

  1. = Mucous membrane of the mouth shiny and tightening/ saliva foamy or mucous/ little clear saliva at the base of the mouth
  2. = Mouth completely dry, mirror sticking to cheek or tongue, mucous membranes often reddened/ bumps on tongue surface disappeared/ scab on melting
2 months

Collaborators and Investigators

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

Sponsor

Koite Health Oy

Collaborators

Karolinska Institutet
University of Helsinki

Investigators

  • Study Director: Tommi Pätilä, Docent, Koite Health
  • 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 (Estimated)

January 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FlexKoi2022

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

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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