Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05425784
• Other study ID #: LumoNorth2022
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: Koite Health Oy
• Contact: Mikko Kylmänen
• Phone: +358407245934
• Email: mikko.kylmanen[@]koitehealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 28, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Lumoral treatment
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.

Other:
• Standard oral hygiene self care
Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.

Locations

Country	Name	City	State
Finland	Mehiläinen Länsi-Pohja Central Hospital	Kemi	Lappi
Finland	Hammas Hohde Oy	Oulu	Oulun Lääni
Finland	Terveystalo	Oulu
Finland	City of Rovaniemi Health Cervices, Oral Health	Rovaniemi

Sponsors (3)

Lead Sponsor	Collaborator
Koite Health Oy	University of Helsinki, University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Reduction in aMMP-8 measurement	Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 3 months compared to baseline	3 months
Secondary	Reduction in aMMP-8 measurement	Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 6 months compared to baseline	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review.
•   Joshi K, Baiju CS, Khashu H, Bansal S (2020) Clinical effectiveness of indocyanine green mediated antimicrobial photodynamic therapy as an adjunct to scaling root planing in treatment of chronic periodontitis- A randomized controlled clinical trial.
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•   Nikinmaa S, Alapulli H, Auvinen P, et al. (2020) Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation.
•   Nikinmaa S, Moilanen N, Sorsa T, et al. (2021a). Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque.
•   Nikinmaa S, Podonyi A, Raivio P, et al. (2021b). Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus.
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