search
Back to results

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

Primary Purpose

Inflamed Gums, Dryness Oral, Plaque

Status
Suspended
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lumoral Treatment
Standard oral hygiene instructions
Sponsored by
Koite Health Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflamed Gums focused on measuring Lumoral, Lumorinse, Plaque, Anti-bacterial photodynamic therapy, aPDT, aMMP-8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pilträdets servicehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Study group

Control group

Arm Description

Use of Lumoral Treatment device. Standard oral hygiene instructions.

Standard oral hygiene instructions.

Outcomes

Primary Outcome Measures

Oral hygiene
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.
Visual Plaque Index (VPI)
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
Bleeding on Probing (BOP)
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
Probing Pocket Depth (PPD)
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)
aMMP-8
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.
Dry mouth
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) = Mucous membrane of the mouth shiny and tightening/ saliva foamy or mucous/ little clear saliva at the base of the mouth = Mouth completely dry, mirror sticking to cheek or tongue, mucous membranes often reddened/ bumps on tongue surface disappeared/ scab on melting

Secondary Outcome Measures

Full Information

First Posted
January 19, 2023
Last Updated
August 30, 2023
Sponsor
Koite Health Oy
Collaborators
University of Helsinki, Karolinska Institutet
search

1. Study Identification

Unique Protocol Identification Number
NCT05720104
Brief Title
Regular Antibacterial Photodynamic Therapy on Oral Hygiene in the Elderly 24-hour Care
Official Title
Effect of Regular Antibacterial Photodynamic Therapy on Oral Hygiene in the Elderly 24-hour Care Residents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Too few patients at site. New sites will be included in the study, we can not be sure of how long it takes. The new sites will then need a re-application to the ethical board, and also the Swedish biobank agreements needs to be changed accordingly.
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koite Health Oy
Collaborators
University of Helsinki, Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflamed Gums, Dryness Oral, Plaque
Keywords
Lumoral, Lumorinse, Plaque, Anti-bacterial photodynamic therapy, aPDT, aMMP-8

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants in two groups (Study group and Control group) shall receive instructions for standard oral hygiene. The same assessments are done for participants in both groups, and within the same time periods. The Study group will also be using the Lumoral Treatment device.
Masking
None (Open Label)
Masking Description
Participants in two groups (Study group and Control group) shall receive instructions for standard oral hygiene. The same assessments are done for participants in both groups, and within the same time periods.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Use of Lumoral Treatment device. Standard oral hygiene instructions.
Arm Title
Control group
Arm Type
Other
Arm Description
Standard oral hygiene instructions.
Intervention Type
Device
Intervention Name(s)
Lumoral Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard oral hygiene instructions
Intervention Description
Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.
Primary Outcome Measure Information:
Title
Oral hygiene
Description
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.
Time Frame
2 months
Title
Visual Plaque Index (VPI)
Description
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
Time Frame
2 months
Title
Bleeding on Probing (BOP)
Description
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
Time Frame
2 months
Title
Probing Pocket Depth (PPD)
Description
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)
Time Frame
2 months
Title
aMMP-8
Description
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.
Time Frame
2 months
Title
Dry mouth
Description
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) = Mucous membrane of the mouth shiny and tightening/ saliva foamy or mucous/ little clear saliva at the base of the mouth = Mouth completely dry, mirror sticking to cheek or tongue, mucous membranes often reddened/ bumps on tongue surface disappeared/ scab on melting
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommi Pätilä, Docent
Organizational Affiliation
Koite Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Timo Sorsa, Professor
Organizational Affiliation
University of Helsinki
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pilträdets servicehus
City
Stockholm
ZIP/Postal Code
11224
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23786637
Citation
De Visschere L, de Baat C, De Meyer L, van der Putten GJ, Peeters B, Soderfelt B, Vanobbergen J. The integration of oral health care into day-to-day care in nursing homes: a qualitative study. Gerodontology. 2015 Jun;32(2):115-22. doi: 10.1111/ger.12062. Epub 2013 Jun 20.
Results Reference
background
PubMed Identifier
21923714
Citation
Holmen A, Stromberg E, Hagman-Gustafsson ML, Wardh I, Gabre P. Oral status in home-dwelling elderly dependent on moderate or substantial supportive care for daily living: prevalence of edentulous subjects, caries and periodontal disease. Gerodontology. 2012 Jun;29(2):e503-11. doi: 10.1111/j.1741-2358.2011.00507.x. Epub 2011 Sep 19.
Results Reference
background
PubMed Identifier
16463570
Citation
Hugoson A, Koch G, Gothberg C, Helkimo AN, Lundin SA, Norderyd O, Sjodin B, Sondell K. Oral health of individuals aged 3-80 years in Jonkoping, Sweden during 30 years (1973-2003). II. Review of clinical and radiographic findings. Swed Dent J. 2005;29(4):139-55.
Results Reference
background
PubMed Identifier
35723308
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.
Results Reference
background
PubMed Identifier
32374766
Citation
Nikinmaa S, Alapulli H, Auvinen P, Vaara M, Rantala J, Kankuri E, Sorsa T, Meurman J, Patila T. Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. PLoS One. 2020 May 6;15(5):e0232775. doi: 10.1371/journal.pone.0232775. eCollection 2020.
Results Reference
background
PubMed Identifier
34063662
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.
Results Reference
background
PubMed Identifier
34680821
Citation
Nikinmaa S, Podonyi A, Raivio P, Meurman J, Sorsa T, Rantala J, Kankuri E, Tauriainen T, Patila T. Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus. Antibiotics (Basel). 2021 Oct 13;10(10):1240. doi: 10.3390/antibiotics10101240.
Results Reference
background
PubMed Identifier
31477059
Citation
Nishizawa T, Niikura Y, Akasaka K, Watanabe M, Kurai D, Amano M, Ishii H, Matsushima H, Yamashita N, Takizawa H. Pilot study for risk assessment of aspiration pneumonia based on oral bacteria levels and serum biomarkers. BMC Infect Dis. 2019 Sep 2;19(1):761. doi: 10.1186/s12879-019-4327-2.
Results Reference
background
PubMed Identifier
31654530
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.
Results Reference
background
PubMed Identifier
34313976
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.
Results Reference
background
PubMed Identifier
29546776
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.
Results Reference
background
PubMed Identifier
22023222
Citation
Willumsen T, Karlsen L, Naess R, Bjorntvedt S. Are the barriers to good oral hygiene in nursing homes within the nurses or the patients? Gerodontology. 2012 Jun;29(2):e748-55. doi: 10.1111/j.1741-2358.2011.00554.x. Epub 2011 Oct 24.
Results Reference
background
Links:
URL
https://link.springer.com/article/10.1007/s41547-019-00056-9
Description
Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review. Laser Dent Sci 3, 147-153 (2019)
URL
https://www.fda.gov/media/75892/download
Description
Levine JI (1990). Medications that increase photosensititivity. FDA document Dec 1990.
URL
https://www.un.org/development/desa/pd/sites/www.un.org.development.desa.pd/files/files/documents/2020/Jan/un_2002_world_population_prospects-2002_revision_volume-ii.pdf
Description
United Nations Population Division. World Population Prospects: The 2002 Revision. New York, NY, USA: United Nations, 2003.

Learn more about this trial

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

We'll reach out to this number within 24 hrs