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Completed

NCT Number: NCT05698823

Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology

Kaunas, 50161, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Periodontal disease stage III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss.
  • ≥ 18 years old
  • Presence of ≥20 teeth, including implants
  • Agreement to participate in the study and to sign a written consent form
  • Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol

Exclusion criteria

  • Grade A or C periodontitis
  • Presence of any physical limitation or restriction that might restrict Lumoral use
  • Pregnancy or lactation
  • Active smoking
  • Medicated diabetes mellitus (DM)
  • Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
  • Use of antibiotics within 4 weeks week prior study
  • Periodontal treatment within 3 months prior study
  • Removable major prosthesis or major orthodontic appliance
  • A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment

Treatment and study plan

Lumoral Treatment

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.

Primary outcomes

  1. Bleeding on probing (BOP)

    Time frame: 6 months

    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

Secondary outcomes

  1. Active matrix metalloproteinase 8 (aMMP-8)

    Time frame: 6 months

    Change in periodontal inflammation marker aMMP-8

  2. Visible plaque index (VPI)

    Time frame: 6 months

    Change in visible plaque index (VPI)

  3. Probing pocket depth (PPD)

    Time frame: 6 months

    Change in probing pocket depth (PPD)

  4. Clinical attachment level (CAL)

    Time frame: 6 months

    Change in clinical attachment level (CAL)

  5. Deep periodontal pockets (over 4 mm)

    Time frame: 6 months

    Change in the number of deep periodontal periodontal pockets (over 4 mm)

  6. Periodontal microbiological flora

    Time frame: 6 months

    Change in periodontal microbiological flora during the study period

  7. Additional visits

    Time frame: 6 months

    Number of additional visits due to periodontitis status between 2nd and 3rd follow-up visits

  8. OHIP-14

    Time frame: 6 months

    Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire

Other outcomes

  1. Device-related adverse event

    Time frame: 6 months

    Absence of device-related serious adverse events or any patterns of device-related adverse events graded as moderate

Sponsors and collaborators

Lead sponsor

Koite Health Oy

Industry

Collaborators

  • Lithuanian University of Health Sciences
  • University of Helsinki

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 26, 2023
Registry last updated
Mar 19, 2026

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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