NCT06486012

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Wellbeing Services County of Pirkanmaa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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.

Conditions

• Diabetes Mellitus, Type 2
• Pre-diabetes
• Periodontal Diseases
• Periodontitis

Interventions

Type	Name	Description
DEVICE	Lumoral Treatment	Photodynamic antibacterial dual-light device home-use with a marker substance
OTHER	Standard oral hygiene	Standard oral hygiene performed at home

Timeline

• Start date: 2025-01-23
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-07-03
• Last updated: 2025-08-06

Locations

1 site across 1 country: Finland