This study is designed to determine the efficacy of the Lumoral method in chronic periodontitis with a targeted group of stage III and IV periodontitis. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the method might have a photobiomodulation effect on periodontal tissues.
The Lumoral Treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy (aPDT). The device is used by swishing a specially designed mouth rinse that strongly adheres to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown promising anti-inflammatory responses in addition to plaque reduction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
The Lumoral treatment -device is a CE-marked antibacterial home-use device for the treatment and prevention of oral diseases caused by bacteria. It is used in combination with a CE-marked mouth rinse called Lumorinse.
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology
Kaunas, Lithuania
Bleeding on probing (BOP)
Improvement in bleeding on probing (BOP) * A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) * Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus * Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent" * BOP is reported as the percentage (%) of sites with positive findings * Calculation formula: number of bleeding sites/ 6 times number of teeth
Time frame: 6 months
Active matrix metalloproteinase 8 (aMMP-8)
Change in periodontal inflammation marker aMMP-8
Time frame: 6 months
Visible plaque index (VPI)
Change in visible plaque index (VPI)
Time frame: 6 months
Probing pocket depth (PPD)
Change in probing pocket depth (PPD)
Time frame: 6 months
Clinical attachment level (CAL)
Change in clinical attachment level (CAL)
Time frame: 6 months
Deep periodontal pockets (over 4 mm)
Change in the number of deep periodontal periodontal pockets (over 4 mm)
Time frame: 6 months
Periodontal microbiological flora
Change in periodontal microbiological flora during the study period
Time frame: 6 months
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Additional visits
Number of additional visits due to periodontitis status between 2nd and 3rd follow-up visits
Time frame: 6 months
OHIP-14
Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire
Time frame: 6 months