Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis

Study Overview
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Brief Summary
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This early-stage research is designed to determine the efficacy of the Lumoral method in chronic periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Detailed Description
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Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque. The Lumoral 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, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.

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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Periodontal Diseases, Periodontitis, Plaque, Dental, Plaque Induced Gingivitis

Intervention / Treatment
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* Device: Lumoral treatment
* Other: Standard oral hygiene self care


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, 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: Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol Removable major prosthesis or major orthodontic appliance Pregnancy or lactation Use of antibiotics within 2 weeks prior the study A need for immediate antimicrobial treatment for periodontitis

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
Interventional Model Description: 90 participants are randomized into two arms: the Lumoral-treatment arm and Control arm.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumoral Treatment (Study group)<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 five to seven (5-7) times a week. Regular use shall be defined as frequency of a minimum of twice a week. Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects. | Device: Lumoral treatment<br>* The investigational Lumoral treatment -device provides a constant and repeatable application which can be done at home and is easily available. All subjects in the study group will receive their own Lumoral treatment -device and Lumorinse-mouth rinse tablets for the complete duration of the study.<br>* Other names: Lumorinse mouth rinse;Other: Standard oral hygiene self care<br>* Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.<br>* Other names: Electric toothbrush provided;|
| Active Comparator: Standard of care (Control group)<br>Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects. | Other: Standard oral hygiene self care<br>* Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.<br>* Other names: Electric toothbrush provided;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in dental inflammation | Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 3 months compared to baseline | 3 months | 
| Reduction in dental inflammation | Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 6 months compared to baseline | 6 months | 
| Stabilization of the periodontal disease | Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 3 months compared to baseline | 3 months | 
| Stabilization of the periodontal disease | Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 6 months compared to baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in aMMP-8 measurement | Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 3 months compared to baseline | 3 months | 
| Reduction in aMMP-8 measurement | Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 6 months compared to baseline | 6 months | 
| Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status | Clinical improvement of periodontitis measured by probing pocket depth (PPD) at 3 months based on the absolute values of PPD. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N. | 3 months | 
| Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status | Clinical improvement of periodontitis measured by probing pocket depth (PPD) at 6 months based on the absolute values of PPD. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N. | 6 months | 
| Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status | Clinical improvement of periodontitis measured by clinical attachment level (CAL) at 3 months based on the absolute values of CAL. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N. | 3 months | 
| Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status | Clinical improvement of periodontitis measured by clinical attachment level (CAL) at 6 months based on the absolute values of CAL. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N. | 6 months | 
| Change in periodontal microbiological pathogens. | Clinical improvement in periodontal microbiological pathogens at 3 months compared to baseline. The microbiological evaluation is the Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis. Microbiological sample will be collected using so called Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points will then be be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis. | 3 months | 
| Change in periodontal microbiological pathogens. | Clinical improvement in periodontal microbiological pathogens at 6 months compared to baseline. The microbiological evaluation is the Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis. Microbiological sample will be collected using so called Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points will then be be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis. | 6 months | 
| Improvement in oral-related quality of life. | Patient related objectives: Improvement in oral-related quality of life measurement (OHIP-14) questionnaire at baseline, at 3 months compared to baseline. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'. | 3 months | 
| Improvement in oral-related quality of life. | Patient related objectives: Improvement in oral-related quality of life measurement (OHIP-14) questionnaire at baseline, at 6 months compared to baseline. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumoral, Lumorinse, Plaque, Periodontitis, Plaque control, aPDT, aMMP-8