Investigation of the effectiveness of a light device called Lumoral for antibacterial photodynamic therapy in patients undergoing supportive periodontal therapy
Summary description of the study
In this study, we aim to find out whether the additional application of a special light device called "Lumoral" can effectively reduce bacteria in the mouth of patients undergoing supportive periodontal therapy in addition to the treatment. 60 patients will be randomly divided into two groups. One group will use the Lumoral device for 4 additional days according to the instructions after the usual dental hygiene session at home, while the other group will not use the Lumoral device. After 8 weeks, we will compare the bacteria and inflammation in both groups, without knowing who was in which group. Our goal is to determine whether the light device can better remove bacteria and reduce gum inflammation.
(BASEC)
Intervention under investigation
The intervention being studied is the application of a light device called "Lumoral" for antibacterial photodynamic therapy (aPDT). The Lumoral light device is a medical product that uses a combination of antibacterial blue light and a photosensitizing agent (dye as a rinse). By targeting bacterial biofilms with blue light, the agent is activated, releasing oxygen radicals that kill bacteria. The Lumoral device is designed for self-application at home. In the test group, patients are instructed to use the Lumoral light device for 4 consecutive days according to the instructions.
(BASEC)
Disease under investigation
This study will be conducted with patients who have treated periodontitis. Periodontitis is an inflammatory disease of the tooth-supporting apparatus caused by bacteria in dental plaque. If the bacteria in the dental plaque and in the pocket between the tooth and gum are left untreated, the inflammation can spread and lead to tissue destruction in the jawbone and eventual tooth loss. Although thorough mechanical cleaning of the teeth can reduce the risk of periodontitis, it is sometimes difficult for patients to clean all affected areas themselves.
(BASEC)
- adult (at least 18 years old) - undergoing supportive periodontal therapy - pocket depths not deeper than 6 mm - Oral bleeding index of ≤ 30% - Signed study information (BASEC)
Exclusion criteria
- Severe systemic diseases - Smoking more than 10 cigarettes/day - Pregnant or breastfeeding (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
None
(BASEC)
Contact
Contact Person Switzerland
Christopf Ramseier
+41316840620
christoph.ramseier@clutterunibe.chUniversity of Bern
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
12.11.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Clinical outcomes following dual-light photodynamic therapy administered daily during supportive periodontal therapy: an 8-week randomized clinical trial (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available