Use of Dual-light Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers
NCT ID: NCT05962801
Last Updated: 2023-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-01-23
2024-09-01
Brief Summary
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• 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lumoral users
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 device, Lumorinse
Regular use of dual-light photodynamic therapy at home
Lumoral non-users
No use of Lumoral device and Lumorinse mouthwash. Performance of oral hygiene twice per day for 6 months.
No interventions assigned to this group
Interventions
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Lumoral device, Lumorinse
Regular use of dual-light photodynamic therapy at home
Eligibility Criteria
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Inclusion Criteria
* aged ≥35
* Smokers smoking ≥10 cigarettes per day
Exclusion Criteria
* Patients with active carious lesions
* Need for prophylactic antimicrobial coverage
* Scaling and root planing in the previous 6 months
* Non-smoking status or smoking less than 10 cigarettes per day
* Antimicrobial therapy in the previous 6 months
* Immunomodifying conditions/ diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis)
* Long-term use of medication that could interfere with periodontal response (e.g. biphosphonates)
* Pregnancy or lactation
35 Years
ALL
Yes
Sponsors
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University of Helsinki
OTHER
Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Dimitra Sakellari
Professor
Principal Investigators
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Dimitra Sakellari, Professor
Role: STUDY_DIRECTOR
Aristotle University Of Thessaloniki
Locations
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Dental School of Aristotle University of Thessaloniki
Thessaloniki, , Greece
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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176/30-11-2022
Identifier Type: -
Identifier Source: org_study_id
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