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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
| Koite Health Oy | INDUSTRY |
| Hammasklinikka Kruunu | UNKNOWN |
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The aim of this study is to determine the effect of regular antibacterial photodynamic Lumoral® treatment on gingival health and plaque volume, and anti-inflammatory effect of daily double light therapy on implant teeth. The study will use a medical device containing a light-activated Lumorinse® mouthwash and a Lumoral® light activator.
The hypothesis is that antibacterial photodynamic therapy improves tissue health by reducing inflammation without any side effect.
Study participants will be invited from a dental clinic in Tampere, Finland, from the patients of an oral hygienist's office. Participants will be randomized to the treatment and control groups using the closed envelope method. Participants in the treatment group will receive Lumoral® treatment according to the manufacturer's protocol, once daily for 10 min for 15 days and then twice daily for 15 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Lumoral and standard treatment |
|
| Control group | Other | Standard treatment only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumoral Treatment | Device | Photodynamic antibacterial dual-light device with a marker substance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Active matrix metalloproteinase 8 (aMMP-8) | Change in periodontal inflammation marker aMMP-8 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing (BOP) | Improvement 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Any antibiotic medication within 6 months prior to study participation
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| Name | Affiliation | Role |
|---|---|---|
| Hanna Lähteenmäki, Doctor | Hammasklinikka Kruunu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammasklinikka Kruunu Oy | Tampere | Pirkanmaa | 33200 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24428439 | Background | Dhir S, Mahesh L, Kurtzman GM, Vandana KL. Peri-implant and periodontal tissues: a review of differences and similarities. Compend Contin Educ Dent. 2013 Jul-Aug;34(7):e69-75. | |
| 18610739 | Background | Matsubara T, Kusuzaki K, Matsumine A, Satonaka H, Shintani K, Nakamura T, Uchida A. Methylene blue in place of acridine orange as a photosensitizer in photodynamic therapy of osteosarcoma. In Vivo. 2008 May-Jun;22(3):297-303. |
| Label | URL |
|---|---|
| Berglundh, T., Lindhe, J., Jonsson, K., \& Ericsson, I. (1994). The topography of the vascular systems in the periodontal and peri-implant tissues in the dog. Journal of Clinical Periodontology, 21(3). | View source |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Randomized
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Participants will be randomized at the end of baseline visit
| Standard treatment for peri-implantitis | Other | Standard treatment for peri-implantitis as per international, national and clinic guidelines |
|
| 30 days |
| Visible plaque index (VPI) | Change in visible plaque index | 30 days |
| 31473032 | Background | Raisanen IT, Heikkinen AM, Nwhator SO, Umeizudike KA, Tervahartiala T, Sorsa T. On the diagnostic discrimination ability of mouthrinse and salivary aMMP-8 point-of-care testing regarding periodontal health and disease. Diagn Microbiol Infect Dis. 2019 Dec;95(4):114871. doi: 10.1016/j.diagmicrobio.2019.114871. Epub 2019 Jul 26. |
| 24660205 | Background | Salvi GE, Zitzmann NU. The effects of anti-infective preventive measures on the occurrence of biologic implant complications and implant loss: a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:292-307. doi: 10.11607/jomi.2014suppl.g5.1. |
| 25496187 | Background | Schwarz F, Becker K, Sager M. Efficacy of professionally administered plaque removal with or without adjunctive measures for the treatment of peri-implant mucositis. A systematic review and meta-analysis. J Clin Periodontol. 2015 Apr;42 Suppl 16:S202-13. doi: 10.1111/jcpe.12349. |
| 25233975 | Background | Shinwari MS, Tanwir F, Hyder PR, Bin Saeed MH. Host modulation therapeutics in periodontics: role as an adjunctive periodontal therapy. J Coll Physicians Surg Pak. 2014 Sep;24(9):676-84. |
| 25185675 | Background | Smeets R, Henningsen A, Jung O, Heiland M, Hammacher C, Stein JM. Definition, etiology, prevention and treatment of peri-implantitis--a review. Head Face Med. 2014 Sep 3;10:34. doi: 10.1186/1746-160X-10-34. |
| 28905941 | Background | Sorsa T, Gieselmann D, Arweiler NB, Hernandez M. A quantitative point-of-care test for periodontal and dental peri-implant diseases. Nat Rev Dis Primers. 2017 Sep 14;3:17069. doi: 10.1038/nrdp.2017.69. No abstract available. |
| 19627514 | Background | Sorsa T, Hernandez M, Leppilahti J, Munjal S, Netuschil L, Mantyla P. Detection of gingival crevicular fluid MMP-8 levels with different laboratory and chair-side methods. Oral Dis. 2010 Jan;16(1):39-45. doi: 10.1111/j.1601-0825.2009.01603.x. Epub 2009 Jul 8. |
| 15533204 | Background | Sorsa T, Tjaderhane L, Salo T. Matrix metalloproteinases (MMPs) in oral diseases. Oral Dis. 2004 Nov;10(6):311-8. doi: 10.1111/j.1601-0825.2004.01038.x. |
| 27833738 | Background | Suarez-Lopez Del Amo F, Yu SH, Wang HL. Non-Surgical Therapy for Peri-Implant Diseases: a Systematic Review. J Oral Maxillofac Res. 2016 Sep 9;7(3):e13. doi: 10.5037/jomr.2016.7313. eCollection 2016 Jul-Sep. |
| 23600659 | Background | Terheyden H, Stadlinger B, Sanz M, Garbe AI, Meyle J. Inflammatory reaction - communication of cells. Clin Oral Implants Res. 2014 Apr;25(4):399-407. doi: 10.1111/clr.12176. Epub 2013 Apr 21. |
| Hentilä, J. et al. (2021). Dual-Light Photodynamic Therapy Effectively Eliminates Streptococcus Oralis Biofilms. Journal of Pharmacy \& Pharmaceutical Sciences, 24 | View source |
| Kilian, M. et al. (2016). The oral microbiome - An update for oral healthcare professionals. British Dental Journal, 221(10). | View source |
| Kormi, I et al. (2014) The effect of prolonged systemic doxycycline therapy on serum tissue degrading proteinases in coronary bypass patients: a randomized, double-masked, placebo-controlled clinical trial. Inflammation Research, 63(5), 329-334 | View source |
| Nikinmaa, S., et al. (2020). Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. PloS One, 15(5). | View source |