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

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Device: Lumoral treatment -device and Lumorinse tablets

• Registration Number: NCT05278416
• Lead Sponsor: Koite Health Oy

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-02-07
• Study Start: 2022-02-08
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Primary Completion: 2025-04-14
• Study Completion: 2025-04-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumoral treatment -device and Lumorinse tablets	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.

Primary Outcome Measures

Name	Time	Method
Bleeding on Probing (BOP)	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 Outcome Measures

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

Trial Locations

Locations (1)

Metropolia University of applied sciences; 🇫🇮 Helsinki, Finland