Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents

NCT05853679 | Completed

• 1 other identifier: RSAA2021
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Around 40 people will participate in the study. The study participants will be recruited from service homes in the City of Helsinki. The subjects will be randomized into two groups. One of the groups will receive daily photodynamic Lumoral treatment for 2 months in a home care unit according to a separate instruction manual. At the beginning of the study, all subjects will receive an oral cleaning and will also be provided with electric toothbrushes. In addition, residents and care home personnel will be instructed on daily tooth cleaning. During the study, all participants will undergo clinical measurements and an assessment of the oral inflammatory load. The samples will be stored for later analysis. In addition, residents or care home personnel answer questions about oral self-care. These measurements and examinations will be carried out at the start of the study and two months after the start of the study. After the end of the study, participants will continue to be treated according to their usual care and individual care plan.

Conditions

Dental Plaque; Pus Collection; Oral Disease; Dryness Oral; Tooth Decay

Keywords

Lumoral; Lumorinse; Plaque Control; Anti-bacterial photodynamic therapy; aMMP-8; Care home

Outcome Measures

Primary Outcomes (3)

• Change in oral hygiene / patient experience

  A change in baseline oral self-care and hygiene questionnaire compared to 2-month follow-up. The questionnaires are completed by the study participants.

  2 months

• Visible Plaque Index

  Change in Visible Plaque Index: * 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

• aMMP-8 chaiside test

  Change in oral inflammatory load measured by the aMMP-8 chairside speed test: * 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. * Further analysis includes aMMP-8 and its regulators by biochemical enzyme/molecule assays, immunoassays, and proteomics analysis.

  2 months

Secondary Outcomes (4)

• Dryness in mouth

  2 months

• Dryness in mouth (patient experience)

  2 months

• Usability of Lumoral Treatment device (patient outcome)

  2 months

• Usability of Lumoral Treatment device (care home personnel outcome)

  2 months

Study Arms (2)

Lumoral Treatment (Study group)

EXPERIMENTAL

A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use. All subjects shall receive new electric toothbrushes, standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.

Device: Lumoral Treatment

Control group

OTHER

A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive new electric toothbrushes, standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.

Device: Lumoral Treatment; Other: Standard oral hygiene instructions according to the Finnish Dental Association

Interventions

Lumoral Treatment DEVICE

The device will be used 5 to 7 times per week according to the manufacturer's instructions.

Control group; Lumoral Treatment (Study group)

Standard oral hygiene instructions according to the Finnish Dental Association OTHER

Participants will be instructed to clean their teeth twice per day by an electric toothbrush, an interdental brush, and flossing.

Control group

Eligibility Criteria

• Age: 60 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)

Sponsors & Collaborators

• Koite Health Oy: lead
• University of Helsinki: collaborator
• City of Helsinki: collaborator

Study Sites (1)

City of Helsinki, Health and Social Services, Senior Services

Helsinki, Uusimaa, 00099, Finland

Location

Related Publications (9)

• 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

• 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, 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

• Nothdurft HD, Jelinek T, Pechel SM, Hess F, Maiwald H, Marschang A, von Sonnenburg F, Weinke T, Loscher T. Stand-by treatment of suspected malaria in travellers. Trop Med Parasitol. 1995 Sep;46(3):161-3.

  PMID: 8533018 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

• Hiltunen K, Julkunen L, Vesa T et al. 2020. Residents' oral health in long-term 24-hour care for the elderly in Helsinki 2018, Studies and reports of the Social and Health Services Department, City of Helsinki Social and Health Services Department
• Suominen L, Vehkalahti M, Knuutila M. Health, functional capacity and well-being in Finland 2011. THL report 68/2012.

MeSH Terms

Conditions

Dental Plaque; Mouth Diseases; Xerostomia; Dental Caries

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Tooth Demineralization

Study Officials

• Timo Sorsa, Professor

  University of Helsinki

  PRINCIPAL INVESTIGATOR

• Riitta Saarela

  City of Helsinki

  STUDY CHAIR

• Tommi Pätilä

  Helsinki University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization of patients is done by using sealed envelope technique at the end of the Baseline visit. During the Baseline visit, participants, care providers, and investigators do not know to which group the participant will be allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 11, 2023
• Study Start: September 1, 2022
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)