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.
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
- Conditions the study is for
- Diabetes Mellitus, Type 2, Pre-diabetes, Periodontal Diseases
- What is being tested?
- Lumoral Treatment and Standard oral hygiene
- Type of treatment
- Pill or oral medicine, Medical device
- 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
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.
Mikko Kylmänen, Master of Health Care contact
Finland1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Standard oral hygiene and home-use of Lumoral Treatment aPDT device. Receives: Device: Lumoral Treatment; Other: Standard oral hygiene |
| Control group | Active comparator | Standard oral hygiene Receives: Other: Standard oral hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted3 Jul 2024
- Study start23 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Randomized clinical study on a medical device.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wellbeing Services County of Pirkanmaa
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Helsinki, Mehiläinen Health Care Services
- Responsible party
- Sponsor
- Investigators
- Anna Maria Heikkinen, Professor, Principal investigator, Wellbeing Services of County Pirkanmaa
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 34234496Choi 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 31882408Gasner 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 32119477Kononen 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 31370168Nazir 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 28539867Liccardo 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 30897827Pakarinen 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 36354651Salminen 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