Recruiting

APDT-T2DAntibacterial Photodynamic Therapy for Diabetic Periodontitis

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Study Aim

This study aims to evaluate whether antibacterial photodynamic therapy can reduce bleeding in the gums of people with diabetic periodontitis.

What is being tested

Lumoral Treatment

+ Standard oral hygiene

DeviceOther
Who is being recruted

Diabetes Mellitus+9

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorWellbeing Services County of Pirkanmaa
Study ContactMiia EhrnroothMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 23, 2025

Actual date on which the first participant was enrolled.

This study explores a new way to manage and prevent gum disease, known as periodontitis, in people with diabetes. High blood sugar levels can increase the risk of periodontitis, while untreated gum disease can worsen blood sugar control. The study aims to improve access to oral healthcare for diabetic patients, focusing on early detection and prevention of oral diseases. It emphasizes the importance of collaboration between diabetes care and oral health services. This approach could help manage both diabetes and gum disease more effectively, improving overall health outcomes and potentially creating cost-effective preventive care pathways. Participants in the study will use a home-based photodynamic therapy, known as aPDT, which involves using dual light therapy to treat gum disease. Additionally, a special test called the aMMP-8 test will be used to assess the risk of periodontal disease and monitor treatment success. This test can activate certain enzymes to provide real-time information about inflammation and help determine how often maintenance treatments are needed. Participants will also be encouraged to improve their oral self-care at home, as this plays a crucial role in preventing oral diseases. The study aims to show that this combination of treatments can improve outcomes for diabetic patients with periodontitis.

Official TitleRegular Use of Antibacterial Photodynamic Therapy in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients - Special Attention to Diabetic Balance and Metabolism
Principal SponsorWellbeing Services County of Pirkanmaa
Study ContactMiia EhrnroothMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHyperglycemiaMetabolic DiseasesStomatognathic DiseasesMouth DiseasesNutritional and Metabolic DiseasesPeriodontal DiseasesPeriodontitisGlucose IntoleranceGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate
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;

Show More Criteria

2 exclusion criteria prevent from participating
Oral thrush;

Known sensitivity to near-infrared or antibacterial blue light.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Standard oral hygiene and home-use of Lumoral Treatment aPDT device.

Group II

Active Comparator
Standard oral hygiene

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Wellbeing Services of County Pirkanmaa

Tampere, FinlandOpen Wellbeing Services of County Pirkanmaa in Google Maps
Recruiting
One Study Center
APDT-T2D | Antibacterial Photodynamic Therapy for Diabetic Periodontitis | PatLynk