Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis

NCT05425784 | Completed

• 1 other identifier: LumoNorth2022
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Keywords

Lumoral; Lumorinse; Plaque; Periodontitis; Plaque control; aPDT; aMMP-8

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Reduction in aMMP-8 measurement

  3 months

• Reduction in aMMP-8 measurement

  6 months

• Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status

  3 months

• Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status

  6 months

• Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status

  3 months

Study Arms (2)

Lumoral Treatment (Study group)

EXPERIMENTAL

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; Other: Standard oral hygiene self care

Standard of care (Control group)

ACTIVE COMPARATOR

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

Interventions

Lumoral treatment DEVICE

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.

Also known as: Lumorinse mouth rinse

Lumoral Treatment (Study group)

Standard oral hygiene self care OTHER

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

Also known as: Electric toothbrush provided

Lumoral Treatment (Study group); Standard of care (Control group)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koite Health Oy: lead
• University of Helsinki: collaborator
• University of Oulu: collaborator

Study Sites (3)

Mehiläinen Länsi-Pohja Central Hospital

Kemi, Lapland, 94100, Finland

Location

Hammas Hohde Oy

Oulu, Oulun Lääni, 90230, Finland

Location

City of Rovaniemi Health Cervices, Oral Health

Rovaniemi, 96100, Finland

Location

Related 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.
• 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.
• Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.
• 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, 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.
• 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.
• 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.
• Slade GD (1997) Derivation and validation of a short-form oral health impact profile

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Dental Plaque; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tommi Pätilä, Docent

  Chief Medical Officer

  STUDY DIRECTOR

• Timo Sorsa, Professor

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The subjects will be randomized to the study group and the control group by using a sealed envelope system.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 90 participants are randomized into two arms: the Lumoral-treatment arm and Control arm.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 21, 2022
• Study Start: January 19, 2023
• Primary Completion: April 29, 2024
• Study Completion: January 13, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)