Diabetes Mellitus, Type 2, Periodontal Diseases, Periodontitis, Pre-diabetes
Conditions
Keywords
periodontitis, diabetes, T2D, aPDT, aMMP-8
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.
Detailed description
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.
Interventions
DEVICELumoral Treatment
Photodynamic antibacterial dual-light device home-use with a marker substance
Standard oral hygiene performed at home
Sponsors
Tampere University
University of Helsinki
Mehiläinen Health Care Services
Wellbeing Services County of Pirkanmaa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data will be collected using individual study codes for participants. Study codes do not reveal which group the participant has belonged to.
Intervention model description
Randomized clinical study on a medical device.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing (BOP) | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal Pocket Depth (PPD) | 6 months | A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm) |
| Clinical Attachment Level (CAL) | 6 months | 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 |
| Active matrix metalloproteinase 8 (aMMP-8) | 6 months | 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. |
| Visual Plaque Index (VPI) | 6 months | 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 |
| Metabolomics | 12 months | 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. |
| hsCRP | 12 months | 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. |
| LPS | 12 months | 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 |
| Periodontopathic bacteria | 6 months | 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 |
Countries
Finland
Contacts
Primary ContactMiia Ehrnrooth
Backup ContactMikko Kylmänen, Master of Health Care
Outcome results
None listed