Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health
Condition: Periodontitis; Plaque, Dental; Plaque Induced Gingivitis
MeSH terms: Gingivitis; Periodontitis; Dental Plaque
Study type: Interventional

Summary: 
      This early-stage study is designed to determine the efficacy of the CE-approved,
      antibacterial, dual-light Lumoral method in 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.
    

Detailed description: 
      Dental plaque triggers changes in gingival health, which results in slight swelling and
      bleeding from the gingival margin and causes gingivitis. Supragingival dental biofilm control
      can be achieved by mechanical and chemical means. Toothbrushing is effective in reducing
      levels of dental plaque (van der Weijden & Slot 2015). It removes plaque from flat,
      accessible surfaces but is less effective at the gingival margins and in approximal areas,
      where the accumulation of residual plaque encourages gingivitis and deterioration of
      periodontal health. Effective toothbrushing is also depending on a number of factors, e.g.,
      age, knowledge, manual dexterity and motivation. Oral hygiene instructions and patient
      motivation in oral hygiene practices should be an integral part of the patient management
      during all stages of periodontal treatment (Tonetti et al., 2015). Oral health practice of
      individuals affects their gingival and periodontal health.

      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. Preliminary results have shown a promising
      anti-inflammatory response in addition to plaque reduction.

      This early-stage study is designed to determine the efficacy of the Lumoral method in
      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.

      Forty (40) patients are randomized to the Lumoral treatment group or the control group. Both
      groups shall receive standard oral hygiene instructions for sonic toothbrush, interdental
      brush, and dental floss use. All the patients shall be assessed for the clinical periodontal
      status including visible plaque index (VPI), bleeding on probing (BOP) and probing pocket
      depth (PPD). In addition, aMMP-8 mouth rinse test and microbiological analysis of gingival
      pockets will be performed. Digital photographs after staining will be taken. These analyses
      shall be performed at baseline and at 4 weeks after the treatment.
    

Intervention name(s): Lumoral device
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Lumorinse mouth rinse
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 20 participants in the treatment (Lumoral) group and 20 participants in the control group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Lumoral; Lumorinse; Plaque; Periodontitis; Plaque control