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NCT Number: NCT06486012

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Pre-diabetes Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellbeing Services of County Pirkanmaa

Tampere, Pirkanmaa, 33520, Finland

Location status: Recruiting

Location contact

Anna Maria Heikkinen, Professor

PRINCIPAL_INVESTIGATOR

Miia Ehrnrooth

CONTACT

[email protected]

+358406615307

Mikko Kylmänen, Master of Health Care

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Lumoral Treatment

Device

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

Standard oral hygiene

Other

Standard oral hygiene performed at home

Primary outcomes

  1. Bleeding on probing (BOP)

    Time frame: 12 months

    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

Secondary outcomes

  1. Visual Plaque Index (VPI)

    Time frame: 6 months

    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

  2. Visual Plaque Index (VPI)

    Time frame: 12 months

    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

  3. Periodontal Pocket Depth (PPD)

    Time frame: 6 months

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

  4. Periodontal Pocket Depth (PPD)

    Time frame: 12 months

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

  5. Clinical Attachment Level (CAL)

    Time frame: 6 months

    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

  6. Clinical Attachment Level (CAL)

    Time frame: 12 months

    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

  7. Active matrix metalloproteinase 8 (aMMP-8)

    Time frame: 6 months

    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.

  8. Active matrix metalloproteinase 8 (aMMP-8)

    Time frame: 12 months

    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.

  9. Periodontopathic bacteria

    Time frame: 6 months

    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

  10. Periodontopathic bacteria

    Time frame: 12 months

    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

  11. Metabolomics

    Time frame: 12 months

    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.

  12. hsCRP

    Time frame: 12 months

    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.

  13. LPS

    Time frame: 12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Miia Ehrnrooth

CONTACT

[email protected]

+358406615307

Mikko Kylmänen, Master of Health Care

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Wellbeing Services County of Pirkanmaa

Other

Collaborators

  • Mehiläinen Health Care Services
  • Tampere University
  • University of Helsinki

Registry information

Official study 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

Acronym: APDT-T2D

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 3, 2024
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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