Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis (HOPE-CP)

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Device: Lumoral treatment -device and Lumorinse tablets

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Metropolia University of Applied Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lumoral treatment -device and Lumorinse tablets; Subjects will receive detailed instructions for the use of Lumoral treatment -device and Lumorinse tablets. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day.	Device: Lumoral treatment -device and Lumorinse tablets; Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol.
No Intervention: Standard of Care; Subjects will receive oral hygiene instructions for the sonic toothbrushing and the use of interdental cleaning devices. They will not receive an additional intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding on Probing (BOP)	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal Pocket Depth (PPD)	A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)	6 months
Clinical Attachment Level (CAL)	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.	6 months
Device-related adverse events	Absence of device-related serious adverse events or any patterns of device-related adverse events graded as moderate	6 months
Inflammation marker aMMP-8 measurement	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.	6 months
Visual Plaque Index (VPI)	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 months
OHIP-14	Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire.	6 months
Patient-related objective: PCS questionnaire	Measurements of internal motivation to dental hygiene by Perceived Competence Scale (PCS) questionnaire.	6 months
Patient-related objective: OSCA questionnaire	Measurements of internal motivation to dental hygiene by Oral Self-Care Assessment (OSCA) questionnaire	6 months

Collaborators and Investigators

• Sponsor: Koite Health Oy
• Collaborators: University of Helsinki; Metropolia University of Applied Sciences
• Investigators: Study Director: Tommi Pätilä, Docent, Koite Health; Principal Investigator: Timo Sorsa, Professor, Univeristy of Helsinki

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): April 14, 2025
• Study Completion (Actual): April 29, 2025

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Periodontitis; Plaque; Lumoral; Lumorinse; aMMP-8; aPDT; Anti-bacterial photodynamic therapy
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Periodontitis; Plaque, Amyloid
• Other Study ID Numbers: KHE2021Metro (HOPE-CP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No