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Completed

NCT Number: NCT05278416

Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis

The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metropolia University of applied sciences

Helsinki, Finland

About this study

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. The device is used by swishing a mouth rinse, strongly adhering to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in long-term use. 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 subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Periodontal disease stage I-III, according to criteria the American Academy of Periodontology (AAP) with at least 2 mm interdental CAL in the site of greatest loss
  • Age of 18-85 years
  • Presence of > 20 teeth
  • Agreement to participate in the study and to sign a written consent form

Exclusion criteria

  • Untreated/uncontrollable diabetes mellitus (DM) with HbA1c >7%, and HbA1c > 8 if insulin treated DM
  • Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
  • Use of medicine that would affect the periodontal tissue within the last 6 months (antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers, including doxycycline, bisphosphonates and chlorhexidine)
  • Periodontal treatment during the previous 3 months
  • Allergic to the photosensitizer
  • Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
  • Removable major prosthesis or major orthodontic appliance
  • Active smoking, or habitual use of smokeless tobacco products
  • Pregnancy or lactation
  • A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment

Treatment and study plan

Lumoral treatment -device and Lumorinse tablets

Device

Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol.

Primary outcomes

  1. Bleeding on Probing (BOP)

    Time frame: 6 months

    Clinical change concerning bleeding on probing change. 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. Clinical Attachment Level (CAL)

    Time frame: 6 months

    Observation of clinical attachment level:

    A full-mouth assessment, measured at six sites per tooth. Assessed as the distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (mm). To calculate CAL, two measurements are needed:

    distance from the gingival margin to the CEJ and PPD; in recession: PPD + gingival margin to the CEJ; in tissue overgrowth: PPD - gingival margin to the CEJ.

  2. Periodontal Pocket Depth (PPD)

    Time frame: 6 months

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

  3. Device-related adverse events

    Time frame: 6 months

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

  4. Inflammation marker aMMP-8 measurement

    Time frame: 6 months

    Change in aMMP8-measurement reflecting the reduction in periodontitis grade. The oral rinse fluid sample collection and the aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions.

  5. Visual Plaque Index (VPI)

    Time frame: 6 months

    Assessment of six index teeth, measured at four 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.

  6. OHIP-14

    Time frame: 6 months

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

  7. Patient-related objective: PCS questionnaire

    Time frame: 6 months

    Measurements of internal motivation to dental hygiene by Perceived Competence Scale (PCS) questionnaire.

  8. Patient-related objective: OSCA questionnaire

    Time frame: 6 months

    Measurements of internal motivation to dental hygiene by Oral Self-Care Assessment (OSCA) questionnaire

Sponsors and collaborators

Lead sponsor

Koite Health Oy

Industry

Collaborators

  • Metropolia University of Applied Sciences
  • University of Helsinki

Registry information

Official study title

Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis.

Acronym: HOPE-CP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2022
Registry last updated
Jan 22, 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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