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

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

Detailed Description
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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.

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

Conditions
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Periodontitis

Intervention / Treatment
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* Device: Lumoral treatment -device and Lumorinse tablets


Participation Criteria
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Eligibility Criteria
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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

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumoral treatment -device and Lumorinse tablets<br>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<br>* Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol.<br>|
| No Intervention: Standard of Care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index | Plaque measurement | 6 months | 
| Bleeding | Clinical change concerning bleeding on probing change | 6 months | 
| pocket depth | measurement of pocket depth | 6 months | 
| Clinical attachment level | observation of clinical attachment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical parameters | Change in aMMP8-measurement reflecting the reduction in periodontitis grade. | 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