Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Periodontal Diseases; Plaque Induced Gingivitis; Plaque, Dental
• Intervention / Treatment: Device: Lumoral treatment; Other: Standard oral hygiene self care

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mikko Kylmänen; Phone Number: +358407245934; Email: mikko.kylmanen@koitehealth.com

Study Locations

• Finland
  • Oulu, Finland, 90100
    • Withdrawn
    • Terveystalo
  • Rovaniemi, Finland, 96100
    • Recruiting
    • City of Rovaniemi Health Cervices, Oral Health
    • Principal Investigator: Timo Sorsa, Professor
    • Contact: Mikko Kylmänen
    • Sub-Investigator: Merja Ylipalosaari, Doctor
  • Lappi
    • Kemi, Lappi, Finland, 94100
      • Recruiting
      • Mehiläinen Länsi-Pohja Central Hospital
      • Principal Investigator: Timo Sorsa, Professor
      • Contact: Mikko Kylmänen
      • Sub-Investigator: Paula Tegelberg, DDS
  • Oulun Lääni
    • Oulu, Oulun Lääni, Finland, 90230
      • Recruiting
      • Hammas Hohde Oy
      • Principal Investigator: Timo Sorsa, Professor
      • Contact: Mikko Kylmänen
      • Sub-Investigator: Meeri Ojala, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumoral Treatment (Study group); 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; 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 Names: Lumorinse mouth rinse; Other: Standard oral hygiene self care; Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.; Other Names: Electric toothbrush provided
Active Comparator: Standard of care (Control group); 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; Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.; Other Names: Electric toothbrush provided

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Koite Health Oy
• Collaborators: University of Helsinki; University of Oulu
• Investigators: Study Director: Tommi Pätilä, Docent, Chief Medical Officer; Principal Investigator: Timo Sorsa, Professor, University of Helsinki

Publications and helpful links

Helpful Links

• 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.
• Slade GD (1997) Derivation and validation of a short-form oral health impact profile
• Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.
• 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.
• Kassebaum NJ, Bernabé E, Dahiya M et al., (2014) Global burden of severe periodontitis in 1990- 2010: a systematic review and meta-regression.
• Kassebaum NJ, Smith AGC, Bernabé E, et al., (2017) Global, Regional and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries
• Lang NP, Suvan JE, Tonetti MS (2015) Risk factor assessment tools for the prevention of periodontitis progression a systematic review.
• Loos BG & Needleman I (2020) Endpoints of active periodontal therapy.
• Monzavi A, Chinipardaz Z, Mousavi M, et al., (2016) Antimicrobial photodynamic therapy using diode laser activated indocyanine green as an adjunct in the treatment of chronic periodontitis: A randomized clinical trial.
• 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.
• Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease.
• Sanz M, Herrera D, Kebschull M, et al.; On behalf of the EFP Workshop Participants and Methodological Consultants. (2020) Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline.
• Lähteenmäki H, Pätilä T, Räisänen IT, et al. (2022). Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease - A Pilot Study.
• Schär D, Ramseier CA, Eick S, et al., (2020) Transgingival photodynamic therapy (tg-aPDT) adjunctive to subgingival mechanical instrumentation in supportive periodontal therapy. A randomized controlled clinical study.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Periodontitis; Plaque; Plaque control; Lumoral; Lumorinse; aMMP-8; aPDT
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Dental Deposits; Chronic Disease; Periodontitis; Gingivitis; Periodontal Diseases; Dental Plaque; Chronic Periodontitis
• Other Study ID Numbers: LumoNorth2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No