Inflamed GumsNCT05720104
Regular Antibacterial Photodynamic Therapy on Oral Hygiene in the Elderly 24-hour Care
A study testing Lumoral Treatment and Standard oral hygiene instructions in people with Inflamed Gums and Dryness Oral, run by Koite Health Oy at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflamed Gums, Dryness Oral, Plaque
- What is being tested?
- Lumoral Treatment and Standard oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Inflamed Gums, Dryness Oral, Plaque
- Being tested
- Lumoral Treatment, Standard oral hygiene instructions
- Keywords
- Lumoral, Lumorinse, Plaque, Anti-bacterial photodynamic therapy, aPDT, aMMP-8
- Medical subject headings
- Gingivitis, Xerostomia, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumoral TreatmentDevice
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.
Standard oral hygiene instructionsOther
Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Use of Lumoral Treatment device. Standard oral hygiene instructions. Receives: Device: Lumoral Treatment; Other: Standard oral hygiene instructions |
| Control group | Other | Standard oral hygiene instructions. Receives: Other: Standard oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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)
- = 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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study startJan 2023 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: No new sites have been found to the
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Inflamed GumsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koite Health Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Tommi Pätilä, Docent, Study director, Koite HealthTimo Sorsa, Professor, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720104
- Sponsor's protocol ID
- FlexKoi2022
- Status last verified
- Oct 2024
- First submitted
- 19 Jan 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23786637Holmen 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.
PubMed 21923714Hugoson 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.
PubMed 16463570Lahteenmaki 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.
PubMed 35723308Nikinmaa 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.
PubMed 32374766Nikinmaa 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.
PubMed 34063662Nikinmaa 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.
PubMed 34680821Nishizawa 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.
PubMed 31477059Saarela 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.
PubMed 31654530Saarela 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.
PubMed 34313976Suominen 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.
PubMed 29546776Willumsen 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.
PubMed 22023222
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Regular Antibacterial Photodynamic Therapy on Oral Hygiene in the Elderly 24-hour Care Residents
- ClinicalTrials.gov ID
- NCT05720104
- Acronym / sponsor ID
- FlexKoi2022
- Conditions
- Inflamed Gums, Dryness Oral, Plaque
- Keywords
- Lumoral, Lumorinse, Plaque, Anti-bacterial photodynamic therapy, aPDT, aMMP-8
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No new sites have been found to the
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Koite Health OyIndustry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, Karolinska Institutet
- Study start
- Jan 2023 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Lumoral Treatment, Other: Standard oral hygiene instructionsUse of Lumoral Treatment device. Standard oral hygiene instructions. |
| Control group | Other | Other: Standard oral hygiene instructionsStandard oral hygiene instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumoral TreatmentSubjects 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. | Device | Study group |
| Standard oral hygiene instructionsSubjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines. | Other | Control group, Study group |
Primary outcome
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.
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
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
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)
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.
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 23786637De 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.
- Background: PubMed 21923714Holmen 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.
- Background: PubMed 16463570Hugoson 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.
- Background: PubMed 35723308Lahteenmaki 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.
- Background: PubMed 32374766Nikinmaa 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.
- Background: PubMed 34063662Nikinmaa 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.
- Background: PubMed 34680821Nikinmaa 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.
- Background: PubMed 31477059Nishizawa 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.
- Background: PubMed 31654530Saarela 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.
- Background: PubMed 34313976Saarela 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.
- Background: PubMed 29546776Suominen 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.
- Background: PubMed 22023222Willumsen 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.
- 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)Link provided by the sponsor.
- Levine JI (1990). Medications that increase photosensititivity. FDA document Dec 1990.Link provided by the sponsor.
- United Nations Population Division. World Population Prospects: The 2002 Revision. New York, NY, USA: United Nations, 2003.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tommi Pätilä, Docent study director
Koite Health
Timo Sorsa, Professor principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumoral Treatment and Standard oral hygiene instructions in people with Inflamed Gums and Dryness Oral, run by Koite Health Oy at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral hygiene (time frame: 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05720104, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.