Clinical trial NCT05962801: Use of Dual-light Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers
Official title: Regular Home Use of Dual-light Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment in Smokers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Dual- Light Photodynamic Therapy
Smoking, Cigarette
Non-surgical Periodontal Therapy
Keywords: periodontitis
periodontal diseases
photodynamic therapy
photothermal therapy
smoking
non-surgical periodontitis therapy
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2023-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in bleeding on probing (BOP)
timeFrame: baseline, 2 weeks, 2 months, 6 months
Secondary outcomes:
measure: Changes of pocket depths
timeFrame: baseline, 2 months, 6 months
measure: Changes in clinical attachment level
timeFrame: baseline, 2 months, 6 months
measure: Difference in the number of "closed" pockets
timeFrame: baseline, 2 months, 6 months
measure: a-MMP8 saliva concentration
timeFrame: baseline, 2 weeks, 2 months, 6 months
measure: Changes in Turetsky Modified Quigley-Hein Plaque Index (TMQHPI)
timeFrame: baseline, 2 weeks, 2 months, 6 months
measure: Oral health-related quality of life questionnaire (OHQL)
timeFrame: 2 months, 6 months
measure: Changes in the presence of periopathogens in the deepest pocket
timeFrame: baseline, 2 months, 6 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Dental School of Aristotle University of Thessaloniki
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Dimitra Sakellari, Professor
role: STUDY_DIRECTOR
References:
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