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

ConditionsDiabetes Mellitus, Type 2Pre-diabetesPeriodontal DiseasesPeriodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWellbeing Services County of Pirkanmaa

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Oral thrush;

Known sensitivity to near-infrared or antibacterial blue light.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lumoral Treatment

    Device

    Photodynamic antibacterial dual-light device home-use with a marker substance

  • Standard oral hygiene

    Other intervention

    Standard oral hygiene performed at home

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Study groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bleeding on probing (BOP)

Change in bleeding on probing (BOP) A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent" BOP is reported as the percentage (%) of sites with positive findings Calculation formula: number of bleeding sites/ 6 times number of teeth

Time frame
12 months

Secondary outcomes

1

Visual Plaque Index (VPI)

Assessment of six index teeth, measured at four sites per tooth: * Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent" * VPI reported as the percentage (%) of sites with plaque * Calculation formula: number of sites with plaque/ 4 times number of teeth

Time frame
6 months
2

Visual Plaque Index (VPI)

Assessment of six index teeth, measured at four sites per tooth: * Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent" * VPI reported as the percentage (%) of sites with plaque * Calculation formula: number of sites with plaque/ 4 times number of teeth

Time frame
12 months
3

Periodontal Pocket Depth (PPD)

A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)

Time frame
6 months
4

Periodontal Pocket Depth (PPD)

A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wellbeing Services County of Pirkanmaa

Lead sponsor

Tampere University

Collaborator

University of Helsinki

Collaborator

Mehiläinen Health Care Services

Collaborator

Source ClinicalTrials.gov
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