Use of Dual-light Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers

Study Overview
=================
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.

Official Title
-----------------
Regular Home Use of Dual-light Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment in Smokers

Conditions
-----------------
Periodontitis, Dual- Light Photodynamic Therapy, Smoking, Cigarette, Non-surgical Periodontal Therapy

Intervention / Treatment
-----------------
* Device: Lumoral device, Lumorinse


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumoral users<br>Use of Lumoral device and Lumorinse mouthwash once per day for 6 months and performance of oral hygiene twice per day for 6 months. | Device: Lumoral device, Lumorinse<br>* Regular use of dual-light photodynamic therapy at home<br>|
| No Intervention: Lumoral non-users<br>No use of Lumoral device and Lumorinse mouthwash. Performance of oral hygiene twice per day for 6 months. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. = Separate flecks of plaque at the cervical margin of the tooth. = A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth. = A band of plaque wider than one mm but covering less than one-third of the crown of the tooth. = Plaque covering at least one-third but less than two thirds of the crown of the tooth. = 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. | baseline, 2 weeks, 2 months, 6 months | 
| Oral health-related quality of life questionnaire (OHQL) | OHQL includes the following questions: Did you use Lumoral® as instructed to you? Did you find Lumoral® easy to use? Did you feel any discomfort when using Lumoral®? Did you discontinue the use of Lumoral® due to this discomfort? Did Lumoral® help you perform oral hygiene? Has bad breath been decreased? Has bleeding of the gums been decreased? Would you recommend Lumoral®? Would you buy Lumoral® if its cost was about 200 €? 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontitis, smoking, periodontal diseases, photodynamic therapy, photothermal therapy, non-surgical periodontitis therapy