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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
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The goal of this controlled clinical trial is to investigate the impact of regular home use of Lumoral device as an adjunct treatment compared to non-surgical periodontitis treatment (NSPT) alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.The main question aims to answer is:
• Does regular use of dual-light photodynamic therapy benefit NSPT in Stage III and Grade C smoking periodontitis patients?
30 participants will be asked to use Lumoral device every night before performing oral hygiene for 10 minutes, while the other 30 patients will be asked to perform only oral hygiene. Both of these groups will receive NSPT and will be followed for 6 months from baseline.
The objective of this study is to investigate the impact of regular home use of Lumoral device® as an adjunct treatment compared to non-surgical periodontal treatment alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.
Lumoral® is based on a dual-wavelength LED light that activates Lumorinse® (exocellular) and bacteria porphyrins (endocellular), resulting in the formation of reactive oxygen species (ROS). ROS and heat induce a series of photochemical and biological events that cause irreversible inactivation leading to the death of undesired bacteria. This device is designed for home use.
Therefore it is hypothesized that its adjunct use in the treatment of periodontitis could lead to better outcomes compared to traditional periodontal treatment. In order to investigate this impact, clinical and microbiological measurements will be compared between patients who will be treated with conventional non-surgical periodontal treatment and patients who will receive the Lumoral device® as an adjunct to the periodontal treatment. The patients who receive the device will use it every day for four months. Both groups will be followed for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumoral users | Active Comparator | Use of Lumoral device and Lumorinse mouthwash once per day for 6 months and performance of oral hygiene twice per day for 6 months. |
|
| Lumoral non-users | No Intervention | No use of Lumoral device and Lumorinse mouthwash. Performance of oral hygiene twice per day for 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumoral device, Lumorinse | Device | Regular use of dual-light photodynamic therapy at home |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bleeding on probing (BOP) | Changes in the presence of bleeding when probing at 6 sites per tooth. It is evaluated dichotomously. | baseline, 2 weeks, 2 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of pocket depths | Changes in measurement in millimeters of the depth from the gingival margin to the epithelial attachment in unhealthy gingival tissue at 6 sites per tooth | baseline, 2 months, 6 months |
| Changes in clinical attachment level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chrysoula Vakaki, Postgraduate | Contact | 0030 6979766034 | vakakichri@gmail.com | |
| Dimitra Sakellari, Professor | Contact | 0030 6945777768 | dimisak@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dimitra Sakellari, Professor | Aristotle University Of Thessaloniki | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental School of Aristotle University of Thessaloniki | Recruiting | Thessaloniki | 54124 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34033939 | Background | AlSarhan MA, Altammami MA, Alaqeely RS, AlEbdi A, Jasser RA, Otaibi DA, Oraini SA, Habib SR, Alqahtani L, Alduhaymi IS, Alrabiah DK, Alaradi M, Alyamani EJ. Short-term improvement of clinical parameters and microbial diversity in periodontitis patients following Indocyanine green-based antimicrobial photodynamic therapy: A randomized single-blind split-mouth cohort. Photodiagnosis Photodyn Ther. 2021 Sep;35:102349. doi: 10.1016/j.pdpdt.2021.102349. Epub 2021 May 24. | |
| 35723308 |
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Patients' data will be recorded in the electronic patients' database of the Dental School of Aristotle University of Thessaloniki and only the researchers of this study will have access to them.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2022 | Sep 30, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D000073865 | Cigarette Smoking |
| D010510 | Periodontal Diseases |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D000073869 | Tobacco Smoking |
| D001519 | Behavior |
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Randomized, controlled clinical trial
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Changes in measurement of the position of the gingival margin in relation to the cemento-enamel junction (CEJ) at 6 sites per tooth
| baseline, 2 months, 6 months |
| Difference in the number of "closed" pockets | Differences in the number of pockets with depth≤ 4mm and no BOP between the test and the control group | baseline, 2 months, 6 months |
| a-MMP8 saliva concentration | Periosafe chair-side tests and the ORALyzer (an advanced lateral flow (aLF) reader) are utilized in order to quantify active MMP-8 in subjects' saliva | baseline, 2 weeks, 2 months, 6 months |
| Changes in Turetsky Modified Quigley-Hein Plaque Index (TMQHPI) | Changes in TMQHPI in buccal surfaces of the upper and lower anterior teeth. A score of 0 to five is assigned to each buccak surface of upper and lower anterior teeth, as follows: 0 = No plaque.
| baseline, 2 weeks, 2 months, 6 months |
| Oral health-related quality of life questionnaire (OHQL) | OHQL includes the following questions:
All questions will be answered with a 'Yes' or 'No' | 2 months, 6 months |
| Changes in the presence of periopathogens in the deepest pocket | Subgingival plaque sample is collected from the deepest pocket of each patient and the presence of periopathogens is detected | baseline, 2 months, 6 months |
| Background |
| Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085. |
| 36135158 | Background | Trujiilo K, Raisanen IT, Sorsa T, Patila T. Repeated Daily Use of Dual-Light Antibacterial Photodynamic Therapy in Periodontal Disease-A Case Report. Dent J (Basel). 2022 Sep 1;10(9):163. doi: 10.3390/dj10090163. |
| 30154936 | Background | Alassiri S, Parnanen P, Rathnayake N, Johannsen G, Heikkinen AM, Lazzara R, van der Schoor P, van der Schoor JG, Tervahartiala T, Gieselmann D, Sorsa T. The Ability of Quantitative, Specific, and Sensitive Point-of-Care/Chair-Side Oral Fluid Immunotests for aMMP-8 to Detect Periodontal and Peri-Implant Diseases. Dis Markers. 2018 Aug 5;2018:1306396. doi: 10.1155/2018/1306396. eCollection 2018. |
| 23895254 | Background | Jansson H, Wahlin A, Johansson V, Akerman S, Lundegren N, Isberg PE, Norderyd O. Impact of periodontal disease experience on oral health-related quality of life. J Periodontol. 2014 Mar;85(3):438-45. doi: 10.1902/jop.2013.130188. Epub 2013 Jul 29. |
| 5264376 | Background | Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available. |
| 30133749 | Background | Chambrone L, Wang HL, Romanos GE. Antimicrobial photodynamic therapy for the treatment of periodontitis and peri-implantitis: An American Academy of Periodontology best evidence review. J Periodontol. 2018 Jul;89(7):783-803. doi: 10.1902/jop.2017.170172. |
| 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. |
| 41196397 | Derived | Vakaki C, Fragkioudakis I, Patila T, Sakellari D. Regular home use of dual-light photodynamic therapy as an adjunct to non-surgical periodontal treatment in smokers: a single-center randomized controlled clinical trial. Clin Oral Investig. 2025 Nov 6;29(12):553. doi: 10.1007/s00784-025-06600-1. |
| D064424 |
| Tobacco Use |