Dental PlaqueNCT05853679
Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents
A study testing Lumoral Treatment and Standard oral hygiene instructions according to the Finnish Dental Association in people with Dental Plaque and Pus Collection, run by Koite Health Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dental Plaque, Pus Collection, Oral Disease
- What is being tested?
- Lumoral Treatment and Standard oral hygiene instructions according to the Finnish Dental Association
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2022to 18 Apr 2023
- 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 60 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)
Trial locations and contacts
1 site in 1 country.
Finland1 site
City of Helsinki, Health and Social Services, Senior Services
Helsinki, Uusimaa, 00099
About this study
Official title: Effect of Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents of a 24-hour Care Facility
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.
Read the detailed description
The aim of this study is to investigate the effect of regular antibacterial photodynamic treatment in service accommodation on the oral hygiene of elderly people. The information from this study can be used to promote oral hygiene among residents in 24-hour care.
Lumoral is a CE-marked medical home appliance that has been shown to be effective in reducing plaque development and the amount of harmful bacteria in plaque. The efficacy of the device is based on an antibacterial photodynamic process, whereby a photosensitive substance in Lumorinse attaches itself to the bacterial coating and is activated as an antibacterial agent by light. The antibacterial effect is directly targeted at the plaque, reducing the impact on the normal oral flora. Preliminary studies have shown that the method reduces the inflammatory factors associated with periodontitis.
The study is being carried out in collaboration with the City of Helsinki Oral Health Department, the Metropolia University of Applied Sciences Oral Care Teaching Hospital and the University of Helsinki Department of Oral and Maxillofacial Surgery. The registrar of the study is the University of Helsinki. The study will be conducted in accordance with Good Clinical Practice (GCP) and ISO 14155 ("Clinical trials on medical devices. Good Clinical Practice").
The target population of the study will be residents in 24-hour care with at least 10 of their own teeth, who are judged by the caregiver to be able to participate in the study and who give written informed consent to participate in the study.
Approximately 40 people will participate in the study. They will be recruited from the City of Helsinki's service homes. The subjects will be randomized into two groups. One of the groups will receive daily photodynamic Lumoral treatment for 2 months in a residential 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 carers will be instructed on daily tooth cleaning.
During the study, all patients will undergo clinical measurements (VPI, CPITN, dry mouth) and an assessment of the oral inflammatory load using the aMMP-8 bowel inflammation test. The occlusion samples will be stored for later analysis. In addition, residents or caregivers 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, subjects 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
- Being tested
- Lumoral Treatment, Standard oral hygiene instructions according to the Finnish Dental Association
- Keywords
- Lumoral, Lumorinse, Plaque Control, Anti-bacterial photodynamic therapy, aMMP-8, Care home
- Medical subject headings
- Dental Plaque, Mouth Diseases, Xerostomia, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumoral TreatmentDevice
The device will be used 5 to 7 times per week according to the manufacturer's instructions.
Standard oral hygiene instructions according to the Finnish Dental AssociationOther
Participants will be instructed to clean their teeth twice per day by an electric toothbrush, an interdental brush, and flossing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Lumoral Treatment; Other: Standard oral hygiene instructions according to the Finnish Dental Association |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 2 months
Secondary outcomes (4)
Dryness in mouth
Change in dryness in mouth. The data will be obtained by the thorough oral inspection performed by the investigators, and by a questionnaire (patient outcome).
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
Dryness in mouth (patient experience)
The data will be obtained by a oral health questionnaire (patient outcome).
Measured: 2 months
Usability of Lumoral Treatment device (patient outcome)
The study participants will answer a questionnaire related to the usability of Lumoral Treatment device.
Measured: 2 months
Usability of Lumoral Treatment device (care home personnel outcome)
The care home nursing staff will answer a questionnaire related to their view of the usability of Lumoral Treatment device. The questionnaire will also ask about how easy or hard it was to instruct the care home patients to use the device on a near-daily basis and if they would recommend the device for further use or to their customers.
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 posted11 May 2023
- Study start1 Sep 2022
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koite Health Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, City of Helsinki
- Responsible party
- Sponsor
- Investigators
- Timo Sorsa, Professor, Principal investigator, University of HelsinkiRiitta Saarela, Study chair, City of HelsinkiTommi Pätilä, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853679
- Sponsor's protocol ID
- RSAA2021
- Status last verified
- Aug 2023
- First submitted
- 21 Apr 2023
- Last updated
- 8 Aug 2023
- 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 23786637Lahteenmaki 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, 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 34063662Nothdurft 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.
PubMed 8533018Nishizawa 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 8 Aug 2023. 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 Elderly Residents of a 24-hour Care Facility
- ClinicalTrials.gov ID
- NCT05853679
- Acronym / sponsor ID
- RSAA2021
- Conditions
- Dental Plaque, Pus Collection, Oral Disease, Dryness Oral, Tooth Decay
- Keywords
- Lumoral, Lumorinse, Plaque Control, Anti-bacterial photodynamic therapy, aMMP-8, Care home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Koite Health OyIndustry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, City of Helsinki
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 11 May 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.
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.
Detailed description
The aim of this study is to investigate the effect of regular antibacterial photodynamic treatment in service accommodation on the oral hygiene of elderly people. The information from this study can be used to promote oral hygiene among residents in 24-hour care.
Lumoral is a CE-marked medical home appliance that has been shown to be effective in reducing plaque development and the amount of harmful bacteria in plaque. The efficacy of the device is based on an antibacterial photodynamic process, whereby a photosensitive substance in Lumorinse attaches itself to the bacterial coating and is activated as an antibacterial agent by light. The antibacterial effect is directly targeted at the plaque, reducing the impact on the normal oral flora. Preliminary studies have shown that the method reduces the inflammatory factors associated with periodontitis.
The study is being carried out in collaboration with the City of Helsinki Oral Health Department, the Metropolia University of Applied Sciences Oral Care Teaching Hospital and the University of Helsinki Department of Oral and Maxillofacial Surgery. The registrar of the study is the University of Helsinki. The study will be conducted in accordance with Good Clinical Practice (GCP) and ISO 14155 ("Clinical trials on medical devices. Good Clinical Practice").
The target population of the study will be residents in 24-hour care with at least 10 of their own teeth, who are judged by the caregiver to be able to participate in the study and who give written informed consent to participate in the study.
Approximately 40 people will participate in the study. They will be recruited from the City of Helsinki's service homes. The subjects will be randomized into two groups. One of the groups will receive daily photodynamic Lumoral treatment for 2 months in a residential 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 carers will be instructed on daily tooth cleaning.
During the study, all patients will undergo clinical measurements (VPI, CPITN, dry mouth) and an assessment of the oral inflammatory load using the aMMP-8 bowel inflammation test. The occlusion samples will be stored for later analysis. In addition, residents or caregivers 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, subjects will continue to be treated according to their usual care and individual care plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumoral Treatment (Study group) | Experimental | Device: Lumoral TreatmentA 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. |
| Control group | Other | Device: Lumoral Treatment, Other: Standard oral hygiene instructions according to the Finnish Dental AssociationA 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. |
Who may qualify
- Ages
- 60 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 (2 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)
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 TreatmentThe device will be used 5 to 7 times per week according to the manufacturer's instructions. | Device | Control group, Lumoral Treatment (Study group) |
| Standard oral hygiene instructions according to the Finnish Dental AssociationParticipants will be instructed to clean their teeth twice per day by an electric toothbrush, an interdental brush, and flossing. | Other | Control group |
Primary outcome
Change in oral hygiene / patient experience
Time frame: 2 months
A change in baseline oral self-care and hygiene questionnaire compared to 2-month follow-up. The questionnaires are completed by the study participants.
Visible Plaque Index
Time frame: 2 months
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
aMMP-8 chaiside test
Time frame: 2 months
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.
4 secondary outcomes
Dryness in mouth
Time frame: 2 months
Dryness in mouth (patient experience)
Time frame: 2 months
Usability of Lumoral Treatment device (patient outcome)
Time frame: 2 months
Usability of Lumoral Treatment device (care home personnel outcome)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- 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 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 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 8533018Nothdurft 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.
- 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.
- 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 DepartmentLink provided by the sponsor.
- Suominen L, Vehkalahti M, Knuutila M. Health, functional capacity and well-being in Finland 2011. THL report 68/2012.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.
Timo Sorsa, Professor principal investigator
University of Helsinki
Riitta Saarela study chair
City of Helsinki
Tommi Pätilä study director
Helsinki University Central Hospital
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 according to the Finnish Dental Association in people with Dental Plaque and Pus Collection, run by Koite Health Oy at 1 site in Finland.
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 2 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: finished, as of the sponsor's last update on 8 Aug 2023. 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 Finland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in oral hygiene / patient experience (time frame: 2 months). The study lists 3 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 NCT05853679, which also lists 9 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 8 Aug 2023.