Regular Home Use of Dual-light Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment in Smokers
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in bleeding on probing (BOP)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Arms & Interventions
Lumoral non-users
No use of Lumoral device and Lumorinse mouthwash. Performance of oral hygiene twice per day for 6 months.
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.
Intervention: Lumoral device, Lumorinse (Device)
Outcomes
Primary Outcomes
Changes in bleeding on probing (BOP)
Time Frame: 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 Outcomes
- Changes of pocket depths(baseline, 2 months, 6 months)
- Oral health-related quality of life questionnaire (OHQL)(2 months, 6 months)
- a-MMP8 saliva concentration(baseline, 2 weeks, 2 months, 6 months)
- Changes in clinical attachment level(baseline, 2 months, 6 months)
- Difference in the number of "closed" pockets(baseline, 2 months, 6 months)
- Changes in Turetsky Modified Quigley-Hein Plaque Index (TMQHPI)(baseline, 2 weeks, 2 months, 6 months)
- Changes in the presence of periopathogens in the deepest pocket(baseline, 2 months, 6 months)
Investigators
Dimitra Sakellari
Professor
Aristotle University Of Thessaloniki