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Diabetes Mellitus, Type 2APDT-T2DNCT06486012

Regular Use of aPDT in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients

A study testing Lumoral Treatment and Standard oral hygiene in people with Diabetes Mellitus, Type 2 and Pre-diabetes, run by Wellbeing Services County of Pirkanmaa at 1 site in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an investigator-initiated clinical study to establish easy referral and access for diabetic patients from primary health care to oral health care facilities for preventive oral care, periodontal assessment, and treatment, and to investigate the impact of regular home use of aPDT medical device on plaque… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lumoral Treatment and Standard oral hygiene
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteFinland
Study dates
23 Jan 2025to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Diabetic patient treated at community health care;
  • At least 18 years old;
  • Presence of ≥20 teeth;
  • Agreement to participate in the study, and to sign a written consent form;
  • Ability to cooperate with the treatment protocol according to coordinator investigator's assessment.

Who cannot join

  • Oral thrush;
  • Known sensitivity to near-infrared or antibacterial blue light.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Miia Ehrnrooth contact

+358406615307

miia.ehrnrooth@mehilainen.fi

Mikko Kylmänen, Master of Health Care contact

mikko.kylmanen@gmail.com

Finland1 site, 1 recruiting

  • Wellbeing Services of County Pirkanmaa

    Tampere, Pirkanmaa, 33520

    Miia Ehrnrooth, +358406615307, miia.ehrnrooth@mehilainen.fi

    Mikko Kylmänen, Master of Health Care, mikko.kylmanen@gmail.com

    Recruiting

Other trials in Finland

About this study

Official title: Regular Use of Antibacterial Photodynamic Therapy in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients - Special Attention to Diabetic Balance and Metabolism

This is an investigator-initiated clinical study to establish easy referral and access for diabetic patients from primary health care to oral health care facilities for preventive oral care, periodontal assessment, and treatment, and to investigate the impact of regular home use of aPDT medical device on plaque control and gingival health, when used as an adjunct treatment to standard oral hygiene, and the effect on diabetes control in patients with the risk of periodontal disease, compared to a standard home care oral hygiene regimen.

Read the detailed description

In earlier studies, a bi-directional link between diabetes and periodontitis has been established: high glucose levels increase the risk of periodontitis while glycemic control is likely to worsen with untreated periodontitis. The treatment of diabetic patients should include easy access from diabetes clinics to oral health care facilities to reduce the potential risks of periodontal disease, or deterioration of existing symptoms of periodontal disease. As part of a holistic approach to healthcare and its resources, more attention needs to be paid to the early detection, and prevention of oral diseases in diabetic patients. Novel testing and treatment methods can play a key role, and a good collaboration between diabetes and oral health care facilities is essential.

The aMMP-8 test can be used to assess the risk of periodontal disease. If the test is positive, latent MMP-8 is activated, so the inflammatory cascade is activated and provides real-time information. The test can also be used to monitor the success of the treatment outcome and can be used to determine the interval between maintenance treatments. In addition, patients' oral self-care should be improved, as most of the work in preventing oral diseases is done at home. The home use of photodynamic dual light therapy (aPDT) can provide additional benefits and also engage patients not only in self-care but also in the whole treatment process. Preliminary studies show that aPDT improves the treatment and maintenance outcomes, and potentially reduces the risk of periodontal disease in addition to self-care.

The combination of easy access to treatment could have wide benefits individually, and also at the community level, including the possibility of building a cost-effective preventive care pathway for patients with prediabetes, type 2 diabetes, and periodontitis, and identifying the risks of both diseases and treating already detected diseases early and in a timely manner.

Being tested
Lumoral Treatment, Standard oral hygiene
Keywords
periodontitis, diabetes, T2D, aPDT, aMMP-8
Medical subject headings
Diabetes Mellitus, Type 2, Glucose Intolerance, Periodontal Diseases, Periodontitis, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lumoral TreatmentDevice

    Photodynamic antibacterial dual-light device home-use with a marker substance

  • Standard oral hygieneOther

    Standard oral hygiene performed at home

Study groups in NCT06486012
Study groupRoleWhat they receive
Study groupExperimentalStandard oral hygiene and home-use of Lumoral Treatment aPDT device.
Receives: Device: Lumoral Treatment; Other: Standard oral hygiene
Control groupActive comparatorStandard oral hygiene
Receives: Other: Standard oral hygiene

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bleeding on probing (BOP)

    Change in bleeding on probing (BOP) A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent" BOP is reported as the percentage (%) of sites with positive findings Calculation formula: number of bleeding sites/ 6 times number of teeth

    Measured: 12 months

Secondary outcomes (13)

  1. Visual Plaque Index (VPI)

    Assessment of six index teeth, measured at four sites per tooth:

    • Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent"
    • VPI reported as the percentage (%) of sites with plaque
    • Calculation formula: number of sites with plaque/ 4 times number of teeth

    Measured: 6 months

  2. Visual Plaque Index (VPI)

    Assessment of six index teeth, measured at four sites per tooth:

    • Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent"
    • VPI reported as the percentage (%) of sites with plaque
    • Calculation formula: number of sites with plaque/ 4 times number of teeth

    Measured: 12 months

  3. Periodontal Pocket Depth (PPD)

    A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)

    Measured: 6 months

  4. Periodontal Pocket Depth (PPD)

    A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)

    Measured: 12 months

  5. Clinical Attachment Level (CAL)

    A full-mouth assessment, measured at six sites per tooth

    Assessed as the distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (mm)

    To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and PPD; in recession: PPD + gingival margin to the CEJ; in tissue overgrowth: PPD - gingival margin to the CEJ

    Measured: 6 months

  6. Clinical Attachment Level (CAL)

    A full-mouth assessment, measured at six sites per tooth

    Assessed as the distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (mm)

    To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and PPD; in recession: PPD + gingival margin to the CEJ; in tissue overgrowth: PPD - gingival margin to the CEJ

    Measured: 12 months

  7. Active matrix metalloproteinase 8 (aMMP-8)

    The oral rinse fluid sample collection and the aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions.

    Measured: 6 months

  8. Active matrix metalloproteinase 8 (aMMP-8)

    The oral rinse fluid sample collection and the aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions.

    Measured: 12 months

  9. Periodontopathic bacteria

    Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis.

    Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis

    Measured: 6 months

  10. Periodontopathic bacteria

    Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis.

    Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis

    Measured: 12 months

  11. Metabolomics

    Nuclear magnetic resonance (NMR) -based metabolomics analysis for biomarkers that include 39 clinically validated routine markers to explore connections between metabolites and an individual's health status.

    Measured: 12 months

  12. hsCRP

    Diagnosis and monitoring of latent inflammation. High-sensitivity CRP tests can determine slight changes to CRP levels within the CRP normal range, which would otherwise be missed by standard tests. Hs-CRP tests can help identify more specific issues and chronic inflammation over the long term.

    Measured: 12 months

  13. LPS

    Gram-negative bacteria-derived lipopolysaccharides (LPS) are known to be associated with various negative health effects. Activity of serum lipopolysaccharides will be measured with Limulus Amebocyte Lysate assay from 1:5 diluted serum samples at 405 nm as an end-point assay

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2024
  2. Study start23 Jan 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Randomized clinical study on a medical device.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06486012
Sponsor's protocol ID
R24021L
Acronym
APDT-T2D
Status last verified
Oct 2026
First submitted
26 Jun 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ahmad R, Haque M. Oral Health Messiers: Diabetes Mellitus Relevance. Diabetes Metab Syndr Obes. 2021 Jul 1;14:3001-3015. doi: 10.2147/DMSO.S318972. eCollection 2021.

    PubMed 34234496

  • Choi SE, Sima C, Pandya A. Impact of Treating Oral Disease on Preventing Vascular Diseases: A Model-Based Cost-effectiveness Analysis of Periodontal Treatment Among Patients With Type 2 Diabetes. Diabetes Care. 2020 Mar;43(3):563-571. doi: 10.2337/dc19-1201. Epub 2019 Dec 27.

    PubMed 31882408

  • Gasner NS, Schure RS. Periodontal Disease. 2025 May 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554590/

    PubMed 32119477

  • Kononen E, Gursoy M, Gursoy UK. Periodontitis: A Multifaceted Disease of Tooth-Supporting Tissues. J Clin Med. 2019 Jul 31;8(8):1135. doi: 10.3390/jcm8081135.

    PubMed 31370168

  • Nazir MA. Prevalence of periodontal disease, its association with systemic diseases and prevention. Int J Health Sci (Qassim). 2017 Apr-Jun;11(2):72-80.

    PubMed 28539867

  • Liccardo D, Cannavo A, Spagnuolo G, Ferrara N, Cittadini A, Rengo C, Rengo G. Periodontal Disease: A Risk Factor for Diabetes and Cardiovascular Disease. Int J Mol Sci. 2019 Mar 20;20(6):1414. doi: 10.3390/ijms20061414.

    PubMed 30897827

  • Pakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206.

    PubMed 36354651

  • Salminen A, Maatta AM, Mantyla P, Leskela J, Pietiainen M, Buhlin K, Suominen AL, Paju S, Sattler W, Sinisalo J, Pussinen PJ. Systemic Metabolic Signatures of Oral Diseases. J Dent Res. 2024 Jan;103(1):13-21. doi: 10.1177/00220345231203562. Epub 2023 Nov 15.

    PubMed 37968796

Questions about this trial

What is this clinical trial studying?

A study testing Lumoral Treatment and Standard oral hygiene in people with Diabetes Mellitus, Type 2 and Pre-diabetes, run by Wellbeing Services County of Pirkanmaa 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 5 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Miia Ehrnrooth (+358406615307, miia.ehrnrooth@mehilainen.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding on probing (BOP) (time frame: 12 months). 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 NCT06486012, which also lists 8 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 2026.

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