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

Aristotle University Of Thessaloniki

Status

Enrolling

Conditions

Periodontitis

Smoking, Cigarette

Dual- Light Photodynamic Therapy

Non-surgical Periodontal Therapy

Treatments

Device: Lumoral device, Lumorinse

Study type

Interventional

Funder types

Other

Identifiers

NCT05962801

176/30-11-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

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