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Completed

NCT Number: NCT05361590

Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care

Tampere, Pirkanmaa, 33520, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old
  • Agreement to participate in the study and to sign a written consent form

Exclusion criteria

  • Presence of any physical limitation or restriction that might restrict Lumoral use
  • Pregnancy or lactation

Treatment and study plan

Lumoral device

Device

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 names: Lumorinse mouth rinse

Primary outcomes

  1. BoP

    Time frame: 4 weeks

    Reduction in bleeding on probing (BoP).

    Procedure for BoP:

    • A full-mouth assessment at six sites per tooth
    • 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 reported as the percentage (%) of sites with positive findings
    • Calculation formula: number of bleeding sites/ 6 times number of teeth

Secondary outcomes

  1. Microbiological pathogens

    Time frame: 4 weeks

    Change in periodontal microbiological pathogens. The plaque sample will be taken from the teeth with ≥3 mm pockets with a sterile paper point. If the subject does not have any deep periodontal pockets, then a sample will be taken from shallow sites. Prior to sampling, the supragingival plaque will be removed with a curette. The paper point will be then taken to the gingival pocket with sterile tweezers. The paper pin will be allowed to stand for 10 to 20 seconds, after which it will be removed and sealed in an empty plastic sample transport tube.

    A gene amplification method (polymerase chain reaction, PCR) will be used to look for six key bacteria in periodontitis: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia and Parvimonas micra.

  2. aMMP-8

    Time frame: 4 weeks

    Reduction in periodontal inflammation marker aMMP-8. An aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions.

  3. VPI

    Time frame: 4 weeks

    Clinical improvement concerning visible plaque index (VPI).

    Procedure for VPI:

    • A full-mouth assessment, measured at 4 sites per tooth
    • Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent"
    • VPI reported as the percentage (%) of sites with plaque
    • Calculation formula: number of sites with plaque/ 4 times number of teeth
  4. PPD

    Time frame: 4 weeks

    Reduction in probing pocket depth (PPD).

    Procedure for PPD:

    • A full-mouth assessment, measured at six sites per tooth
    • Assessed from the base of the pocket to the gingival margin (mm).

Sponsors and collaborators

Lead sponsor

Koite Health Oy

Industry

Collaborators

  • Tampere University
  • University of Helsinki

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 4, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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