An interventional study of Lumoral Treatment and Standard oral hygiene in Diabetes Mellitus, Type 2, Pre-diabetes and Periodontal Diseases, sponsored by Wellbeing Services County of Pirkanmaa. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by Wellbeing Services County of Pirkanmaa · Not applicable, Interventional, and Treatment
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.
In earlier studies, a bi-directional link between diabetes and periodontitis has been established: high glucose levels increase the risk of periodontitis while glycemic control is likely to worsen with untreated periodontitis. The treatment of diabetic patients should include easy access from diabetes clinics to oral health care facilities to reduce the potential risks of periodontal disease, or deterioration of existing symptoms of periodontal disease. As part of a holistic approach to healthcare and its resources, more attention needs to be paid to the early detection, and prevention of oral diseases in diabetic patients. Novel testing and treatment methods can play a key role, and a good collaboration between diabetes and oral health care facilities is essential.
The aMMP-8 test can be used to assess the risk of periodontal disease. If the test is positive, latent MMP-8 is activated, so the inflammatory cascade is activated and provides real-time information. The test can also be used to monitor the success of the treatment outcome and can be used to determine the interval between maintenance treatments. In addition, patients' oral self-care should be improved, as most of the work in preventing oral diseases is done at home. The home use of photodynamic dual light therapy (aPDT) can provide additional benefits and also engage patients not only in self-care but also in the whole treatment process. Preliminary studies show that aPDT improves the treatment and maintenance outcomes, and potentially reduces the risk of periodontal disease in addition to self-care.
The combination of easy access to treatment could have wide benefits individually, and also at the community level, including the possibility of building a cost-effective preventive care pathway for patients with prediabetes, type 2 diabetes, and periodontitis, and identifying the risks of both diseases and treating already detected diseases early and in a timely manner.
9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Wellbeing Services County of Pirkanmaa is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Standard oral hygiene and home-use of Lumoral Treatment aPDT device.
Device: Lumoral Treatment · Other: Standard oral hygiene
Standard oral hygiene
Other: Standard oral hygiene
Photodynamic antibacterial dual-light device home-use with a marker substance
Standard oral hygiene performed at home
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
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
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
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
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
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 12 months
Plan to share: No
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Wellbeing Services County of Pirkanmaa