Regular Use of aPDT in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients (APDT-T2D)

August 5, 2025 updated by: Wellbeing Services County of Pirkanmaa

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Wellbeing Services of County Pirkanmaa
        • Principal Investigator:
          • Anna Maria Heikkinen, Professor
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Standard oral hygiene and home-use of Lumoral Treatment aPDT device.
Device: Lumoral Treatment
Photodynamic antibacterial dual-light device home-use with a marker substance
Other: Standard oral hygiene
Standard oral hygiene performed at home
Active Comparator: Control group
Standard oral hygiene
Other: Standard oral hygiene
Standard oral hygiene performed at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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
6 months
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
12 months
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)
6 months
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)
12 months
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 months
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
12 months
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.
12 months
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
6 months
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
12 months
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.
12 months
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
12 months
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 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wellbeing Services County of Pirkanmaa

Collaborators

University of Helsinki
Tampere University
Mehiläinen Health Care Services

Investigators

  • Principal Investigator: Anna Maria Heikkinen, Professor, Wellbeing Services of County Pirkanmaa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R24021L

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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