Dual- Light Photodynamic Therapy, Non-surgical Periodontal Therapy, Periodontitis, Smoking, Cigarette
Conditions
Keywords
periodontitis, periodontal diseases, photodynamic therapy, photothermal therapy, smoking, non-surgical periodontitis therapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICELumoral device, Lumorinse
Regular use of dual-light photodynamic therapy at home
Sponsors
University of Helsinki
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Periodontal disease Stage III and Grade C with at least 6 sites with probing depth (PD) and clinical attachment loss (CAL) ≥5 mm and bleeding on probing (BoP) ≥15 teeth * aged ≥35 * Smokers smoking ≥10 cigarettes per day
Exclusion criteria
* Patients allergic to indocyanine * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in bleeding on probing (BOP) | baseline, 2 weeks, 2 months, 6 months | Changes in the presence of bleeding when probing at 6 sites per tooth. It is evaluated dichotomously. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in clinical attachment level | baseline, 2 months, 6 months | Changes in measurement of the position of the gingival margin in relation to the cemento-enamel junction (CEJ) at 6 sites per tooth |
| Difference in the number of closed pockets | baseline, 2 months, 6 months | Differences in the number of pockets with depth≤ 4mm and no BOP between the test and the control group |
| a-MMP8 saliva concentration | baseline, 2 weeks, 2 months, 6 months | 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 |
| Changes of pocket depths | baseline, 2 months, 6 months | 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 |
| Oral health-related quality of life questionnaire (OHQL) | 2 months, 6 months | 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' |
| Changes in the presence of periopathogens in the deepest pocket | baseline, 2 months, 6 months | Subgingival plaque sample is collected from the deepest pocket of each patient and the presence of periopathogens is detected |
| Changes in Turetsky Modified Quigley-Hein Plaque Index (TMQHPI) | baseline, 2 weeks, 2 months, 6 months | 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. |
Countries
Greece
Contacts
Primary ContactChrysoula Vakaki, Postgraduate
Backup ContactDimitra Sakellari, Professor
Outcome results
None listed