Regular Use of aPDT in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients
- Conditions
- Pre-diabetesPeriodontitisPeriodontal DiseasesDiabetes Mellitus, Type 2
- Interventions
- Device: Lumoral TreatmentOther: Standard oral hygiene
- Registration Number
- NCT06486012
- Lead Sponsor
- Wellbeing Services County of Pirkanmaa
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- Oral thrush;
- Known sensitivity to near-infrared or antibacterial blue light.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group Standard oral hygiene Standard oral hygiene and home-use of Lumoral Treatment aPDT device. Control group Standard oral hygiene Standard oral hygiene Study group Lumoral Treatment Standard oral hygiene and home-use of Lumoral Treatment aPDT device.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Visual Plaque Index (VPI) 12 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 teethhsCRP 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.
Active matrix metalloproteinase 8 (aMMP-8) 12 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.
Periodontal Pocket Depth (PPD) 12 months A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)
Periodontopathic bacteria 12 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 analysisLPS 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
Clinical Attachment Level (CAL) 12 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 CEJMetabolomics 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.
Trial Locations
- Locations (1)
Wellbeing Services of County Pirkanmaa
🇫🇮Tampere, Pirkanmaa, Finland