Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology
Kaunas, 50161, Lithuania
NCT Number: NCT05698823
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.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Kaunas, 50161, Lithuania
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
Improvement in bleeding on probing (BOP)
Time frame: 6 months
Change in periodontal inflammation marker aMMP-8
Time frame: 6 months
Change in visible plaque index (VPI)
Time frame: 6 months
Change in probing pocket depth (PPD)
Time frame: 6 months
Change in clinical attachment level (CAL)
Time frame: 6 months
Change in the number of deep periodontal periodontal pockets (over 4 mm)
Time frame: 6 months
Change in periodontal microbiological flora during the study period
Time frame: 6 months
Number of additional visits due to periodontitis status between 2nd and 3rd follow-up visits
Time frame: 6 months
Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire
Time frame: 6 months
Absence of device-related serious adverse events or any patterns of device-related adverse events graded as moderate
Koite Health Oy
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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