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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06486012 on ClinicalTrials.gov