Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis
Overview
- Phase
- Not Applicable
- Intervention
- Lumoral Treatment
- Conditions
- Periodontitis Chronic Generalized Moderate
- Sponsor
- Koite Health Oy
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Bleeding on probing (BOP)
- Status
- Completed
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Study group
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.
Intervention: Lumoral Treatment
Control group
A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.
Outcomes
Primary Outcomes
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
- Active matrix metalloproteinase 8 (aMMP-8)(6 months)
- Visible plaque index (VPI)(6 months)
- Deep periodontal pockets (over 4 mm)(6 months)
- Probing pocket depth (PPD)(6 months)
- Clinical attachment level (CAL)(6 months)
- Additional visits(6 months)
- OHIP-14(6 months)
- Periodontal microbiological flora(6 months)