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

Not Applicable

Recruiting

• Conditions: Periodontitis Chronic Generalized Moderate; Periodontitis Chronic Generalized Severe
• Interventions: Device: Lumoral Treatment

• Registration Number: NCT05698823
• Lead Sponsor: Koite Health Oy

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-26
• Study Start: 2023-06-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Lumoral Treatment	A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.

Primary Outcome Measures

Name	Time	Method
Bleeding on probing (BOP)	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 Outcome Measures

Name	Time	Method
Active matrix metalloproteinase 8 (aMMP-8)	6 months	Change in periodontal inflammation marker aMMP-8
Visible plaque index (VPI)	6 months	Change in visible plaque index (VPI)
Deep periodontal pockets (over 4 mm)	6 months	Change in the number of deep periodontal periodontal pockets (over 4 mm)
Probing pocket depth (PPD)	6 months	Change in probing pocket depth (PPD)
Clinical attachment level (CAL)	6 months	Change in clinical attachment level (CAL)
Additional visits	6 months	Number of additional visits due to periodontitis status between 2nd and 3rd follow-up visits
OHIP-14	6 months	Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire
Periodontal microbiological flora	6 months	Change in periodontal microbiological flora during the study period

Trial Locations

Locations (1)

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology; 🇱🇹 Kaunas, Lithuania