Regular Use of aPDT in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients
NCT Number: NCT06486012
Acronym: APDT-T2D
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2|Pre-diabetes|Periodontal Diseases|Periodontitis
Interventions: DEVICE: Lumoral Treatment|OTHER: Standard oral hygiene
Sponsor: Wellbeing Services County of Pirkanmaa
Collaborators: Tampere University|University of Helsinki|Mehiläinen Health Care Services
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-12
Locations: Wellbeing Services of County Pirkanmaa, Tampere, Pirkanmaa, 33520, Finland

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.

Primary Outcome Measures: 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, 12 months
Secondary Outcome Measures: 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, 6 months|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, 12 months|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), 6 months|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), 12 months|Clinical Attachment Level (CAL), A full-mouth assessment, measured at six sites per tooth

Assessed as the distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (mm)

To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and PPD; in recession: PPD + gingival margin to the CEJ; in tissue overgrowth: PPD - gingival margin to the CEJ, 6 months|Clinical Attachment Level (CAL), A full-mouth assessment, measured at six sites per tooth

Assessed as the distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (mm)

To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and PPD; in recession: PPD + gingival margin to the CEJ; in tissue overgrowth: PPD - gingival margin to the CEJ, 12 months|Active matrix metalloproteinase 8 (aMMP-8), The oral rinse fluid sample collection and the aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions., 6 months|Active matrix metalloproteinase 8 (aMMP-8), The oral rinse fluid sample collection and the aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions., 12 months|Periodontopathic bacteria, Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis.

Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis, 6 months|Periodontopathic bacteria, Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis.

Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis, 12 months|Metabolomics, Nuclear magnetic resonance (NMR) -based metabolomics analysis for biomarkers that include 39 clinically validated routine markers to explore connections between metabolites and an individual's health status., 12 months|hsCRP, Diagnosis and monitoring of latent inflammation. High-sensitivity CRP tests can determine slight changes to CRP levels within the CRP normal range, which would otherwise be missed by standard tests. Hs-CRP tests can help identify more specific issues and chronic inflammation over the long term., 12 months|LPS, Gram-negative bacteria-derived lipopolysaccharides (LPS) are known to be associated with various negative health effects. Activity of serum lipopolysaccharides will be measured with Limulus Amebocyte Lysate assay from 1:5 diluted serum samples at 405 nm as an end-point assay, 12 months