Regular Use of aPDT in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients
NCT06486012 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-08-06
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.
Conditions
- Diabetes Mellitus, Type 2
- Pre-diabetes
- Periodontal Diseases
- Periodontitis
Interventions
- DEVICE
-
Lumoral Treatment
Photodynamic antibacterial dual-light device home-use with a marker substance
- OTHER
-
Standard oral hygiene
Standard oral hygiene performed at home
Sponsors & Collaborators
-
Tampere University
collaborator OTHER -
University of Helsinki
collaborator OTHER -
Mehiläinen Health Care Services
collaborator UNKNOWN -
Wellbeing Services County of Pirkanmaa
lead OTHER
Principal Investigators
-
Anna Maria Heikkinen, Professor · Wellbeing Services of County Pirkanmaa
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-23
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
Countries
- Finland
Study Locations
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