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Clinical Trial Summary

This early-stage research is designed to determine the efficacy of the Lumoral method in chronic periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.


Clinical Trial Description

Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque. The Lumoral 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. The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05425784
Study type Interventional
Source Koite Health Oy
Contact Mikko Kylmänen
Phone +358407245934
Email mikko.kylmanen@koitehealth.com
Status Recruiting
Phase N/A
Start date January 19, 2023
Completion date February 28, 2025

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