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

NCT05720104 | Withdrawn

• 1 other identifier: FlexKoi2022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflamed Gums; Dryness Oral; Plaque

Keywords

Lumoral; Lumorinse; Plaque; Anti-bacterial photodynamic therapy; aPDT; aMMP-8

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  2 months

• 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

  2 months

• 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)

  2 months

• 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.

  2 months

• 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) 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

Study Arms (2)

Study group

EXPERIMENTAL

Use of Lumoral Treatment device. Standard oral hygiene instructions.

Device: Lumoral Treatment; Other: Standard oral hygiene instructions

Control group

OTHER

Standard oral hygiene instructions.

Other: Standard oral hygiene instructions

Interventions

Lumoral Treatment DEVICE

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.

Study group

Standard oral hygiene instructions OTHER

Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Koite Health Oy: lead
• University of Helsinki: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Pilträdets servicehus

Stockholm, 11224, Sweden

Location

Related Publications (12)

• 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.

  PMID: 23786637 BACKGROUND

• 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.

  PMID: 21923714 BACKGROUND

• 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.

  PMID: 16463570 BACKGROUND

• 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.

  PMID: 35723308 BACKGROUND

• 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.

  PMID: 32374766 BACKGROUND

• 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.

  PMID: 34063662 BACKGROUND

• 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.

  PMID: 34680821 BACKGROUND

• 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.

  PMID: 31477059 BACKGROUND

• 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.

  PMID: 31654530 BACKGROUND

• 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.

  PMID: 34313976 BACKGROUND

• 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.

  PMID: 29546776 BACKGROUND

• 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.

  PMID: 22023222 BACKGROUND

Related Links

• 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)
• Levine JI (1990). Medications that increase photosensititivity. FDA document Dec 1990.
• United Nations Population Division. World Population Prospects: The 2002 Revision. New York, NY, USA: United Nations, 2003.

MeSH Terms

Conditions

Gingivitis; Xerostomia; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tommi Pätilä, Docent

  Koite Health

  STUDY DIRECTOR

• Timo Sorsa, Professor

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 9, 2023
• Study Start: January 1, 2023
• Primary Completion: October 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)