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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Regular use of dual-light photodynamic therapy at home
Dental School of Aristotle University of Thessaloniki
Thessaloniki, Greece
RECRUITINGChanges in bleeding on probing (BOP)
Changes in the presence of bleeding when probing at 6 sites per tooth. It is evaluated dichotomously.
Time frame: baseline, 2 weeks, 2 months, 6 months
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
Time frame: baseline, 2 months, 6 months
Changes in clinical attachment level
Changes in measurement of the position of the gingival margin in relation to the cemento-enamel junction (CEJ) at 6 sites per tooth
Time frame: 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
Time frame: 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
Time frame: 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. 1. = Separate flecks of plaque at the cervical margin of the tooth. 2. = A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth. 3. = A band of plaque wider than one mm but covering less than one-third of the crown of the tooth. 4. = Plaque covering at least one-third but less than two thirds of the crown of the tooth. 5. = Plaque covering two-thirds or more of the crown of the tooth. An index for the anterior teeth is determined by dividing the total score by the number surfaces examined. The score is rounded up to the second decimal number and it ranges from 0 to 5.
Time frame: baseline, 2 weeks, 2 months, 6 months
Oral health-related quality of life questionnaire (OHQL)
OHQL includes the following questions: 1. Did you use Lumoral® as instructed to you? 2. Did you find Lumoral® easy to use? 3. Did you feel any discomfort when using Lumoral®? 4. Did you discontinue the use of Lumoral® due to this discomfort? 5. Did Lumoral® help you perform oral hygiene? 6. Has bad breath been decreased? 7. Has bleeding of the gums been decreased? 8. Would you recommend Lumoral®? 9. Would you buy Lumoral® if its cost was about 200 €? All questions will be answered with a 'Yes' or 'No'
Time frame: 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
Time frame: baseline, 2 months, 6 months
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