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| Name | Class |
|---|---|
| Tampere University | OTHER |
| University of Helsinki | OTHER |
| Mehiläinen Health Care Services | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Standard oral hygiene and home-use of Lumoral Treatment aPDT device. |
|
| Control group | Active Comparator | Standard oral hygiene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumoral Treatment | Device | Photodynamic antibacterial dual-light device home-use with a marker substance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Plaque Index (VPI) | Assessment of six index teeth, measured at four sites per tooth:
| 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miia Ehrnrooth | Contact | +358406615307 | miia.ehrnrooth@mehilainen.fi | |
| Mikko Kylmänen, Master of Health Care | Contact | mikko.kylmanen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Anna Maria Heikkinen, Professor | Wellbeing Services of County Pirkanmaa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellbeing Services of County Pirkanmaa | Recruiting | Tampere | Pirkanmaa | 33520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34234496 | Background | Ahmad R, Haque M. Oral Health Messiers: Diabetes Mellitus Relevance. Diabetes Metab Syndr Obes. 2021 Jul 1;14:3001-3015. doi: 10.2147/DMSO.S318972. eCollection 2021. | |
| 31882408 | Background | Choi SE, Sima C, Pandya A. Impact of Treating Oral Disease on Preventing Vascular Diseases: A Model-Based Cost-effectiveness Analysis of Periodontal Treatment Among Patients With Type 2 Diabetes. Diabetes Care. 2020 Mar;43(3):563-571. doi: 10.2337/dc19-1201. Epub 2019 Dec 27. |
| Label | URL |
|---|---|
| Bashir, N.Z., Singh, HA. \& Virdee, S.S. Indocyanine green-mediated antimicrobial photodynamic therapy as an adjunct to periodontal therapy: a systematic review and meta-analysis. Clin Oral Invest 25, 5699-5710 (2021). | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| D010510 | Periodontal Diseases |
| D010518 | Periodontitis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Randomized clinical study on a medical device.
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Data will be collected using individual study codes for participants. Study codes do not reveal which group the participant has belonged to.
| Standard oral hygiene | Other | Standard oral hygiene performed at home |
|
| Visual Plaque Index (VPI) |
Assessment of six index teeth, measured at four sites per tooth:
|
| 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 |
| 32119477 | Background | Gasner NS, Schure RS. Periodontal Disease. 2025 May 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554590/ |
| 31370168 | Background | Kononen E, Gursoy M, Gursoy UK. Periodontitis: A Multifaceted Disease of Tooth-Supporting Tissues. J Clin Med. 2019 Jul 31;8(8):1135. doi: 10.3390/jcm8081135. |
| 28539867 | Background | Nazir MA. Prevalence of periodontal disease, its association with systemic diseases and prevention. Int J Health Sci (Qassim). 2017 Apr-Jun;11(2):72-80. |
| 30897827 | Background | Liccardo D, Cannavo A, Spagnuolo G, Ferrara N, Cittadini A, Rengo C, Rengo G. Periodontal Disease: A Risk Factor for Diabetes and Cardiovascular Disease. Int J Mol Sci. 2019 Mar 20;20(6):1414. doi: 10.3390/ijms20061414. |
| 36354651 | Background | Pakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206. |
| 37968796 | Background | Salminen A, Maatta AM, Mantyla P, Leskela J, Pietiainen M, Buhlin K, Suominen AL, Paju S, Sattler W, Sinisalo J, Pussinen PJ. Systemic Metabolic Signatures of Oral Diseases. J Dent Res. 2024 Jan;103(1):13-21. doi: 10.1177/00220345231203562. Epub 2023 Nov 15. |
| Berger, V., Bour, L., Carter, K. et al. A roadmap to using randomization in clinical trials. BMC Med Res Methodol 21, 168 (2021). | View source |
| Borgnakke, W.S., Poudel, P. Front. Dent. Med, Volume 2 - 2021. Diabetes and Oral Health: Summary of Current Scientific Evidence for Why Transdisciplinary Collaboration Is Needed. | View source |
| Centers for Disease Control and Prevention (CDC), July 2023. Periodontal Disease. | View source |
| Sorsa, T, Nwhator, SO, Sakellari, D, Grigoriadis, A, Umeizudike, KA, Brandt, E, Keskin, M, Tervahartiala, T, Pärnänen, P, Gupta, S, Mohindra, R, Bostanci, N, Buduneli, N, Räisänen, IT. Front. Oral Health, 10 June 2022, Sec. Oral Infections and Microbes | View source |
| World Health Organization (WHO). Diabetes, Oct 2023. Newsroom, Fact sheets, Detail, Diabetes. | View source |
| Zhang Y., Leveille S.G., Shi L., Camhi S.M. Disparities in Preventive Oral Health Care and Periodontal Health Among Adults With Diabetes. Prev Chronic Dis 2021;18:200594 | View source |
| D006943 | Hyperglycemia |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |