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Recruiting NCT06486012

NCT06486012 Regular Use of aPDT in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients

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Clinical Trial Summary
NCT ID NCT06486012
Status Recruiting
Phase
Sponsor Wellbeing Services County of Pirkanmaa
Condition Diabetes Mellitus, Type 2
Study Type INTERVENTIONAL
Enrollment 150 participants
Start Date 2025-01-23
Primary Completion 2027-12

Trial Parameters

Condition Diabetes Mellitus, Type 2
Sponsor Wellbeing Services County of Pirkanmaa
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-01-23
Completion 2027-12
Interventions
Lumoral TreatmentStandard oral hygiene

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Brief 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.

Eligibility Criteria

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.

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