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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periodontitis Chronic Generalized Moderate, Periodontitis Chronic Generalized Severe

Intervention / Treatment
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* Device: Lumoral Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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. | Device: Lumoral Treatment<br>* The Lumoral treatment -device is a CE-marked antibacterial home-use device for the treatment and prevention of oral diseases caused by bacteria. It is used in combination with a CE-marked mouth rinse called Lumorinse.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing (BOP) | 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 | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumoral, Lumorinse, Periodontitis, Anti-bacterial photodynamic therapy, aPDT, Plaque, aMMP-8, Photobiomodulation