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Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis

Primary Purpose

Periodontal Diseases, Periodontitis, Plaque, Dental

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Lumoral treatment
Standard oral hygiene self care
Sponsored by
Koite Health Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Lumoral, Lumorinse, Plaque, Periodontitis, Plaque control, aPDT, aMMP-8

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mehiläinen Länsi-Pohja Central HospitalRecruiting
  • Hammas Hohde OyRecruiting
  • Terveystalo
  • City of Rovaniemi Health Cervices, Oral HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lumoral Treatment (Study group)

Standard of care (Control group)

Arm Description

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.

Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects.

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Reduction in aMMP-8 measurement
Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 3 months compared to baseline
Reduction in aMMP-8 measurement
Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 6 months compared to baseline
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.
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.
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.
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.
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.
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.
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'.
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'.

Full Information

First Posted
May 31, 2022
Last Updated
January 30, 2023
Sponsor
Koite Health Oy
Collaborators
University of Helsinki, University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT05425784
Brief Title
Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis
Official Title
Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
November 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koite Health Oy
Collaborators
University of Helsinki, University of Oulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Periodontitis, Plaque, Dental, Plaque Induced Gingivitis
Keywords
Lumoral, Lumorinse, Plaque, Periodontitis, Plaque control, aPDT, aMMP-8

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
90 participants are randomized into two arms: the Lumoral-treatment arm and Control arm.
Masking
ParticipantCare ProviderInvestigator
Masking Description
The subjects will be randomized to the study group and the control group by using a sealed envelope system.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumoral Treatment (Study group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care (Control group)
Arm Type
Active Comparator
Arm Description
Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects.
Intervention Type
Device
Intervention Name(s)
Lumoral treatment
Other Intervention Name(s)
Lumorinse mouth rinse
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard oral hygiene self care
Other Intervention Name(s)
Electric toothbrush provided
Intervention Description
Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.
Primary Outcome Measure Information:
Title
Reduction in dental inflammation
Description
Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 3 months compared to baseline
Time Frame
3 months
Title
Reduction in dental inflammation
Description
Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 6 months compared to baseline
Time Frame
6 months
Title
Stabilization of the periodontal disease
Description
Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 3 months compared to baseline
Time Frame
3 months
Title
Stabilization of the periodontal disease
Description
Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 6 months compared to baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reduction in aMMP-8 measurement
Description
Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 3 months compared to baseline
Time Frame
3 months
Title
Reduction in aMMP-8 measurement
Description
Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 6 months compared to baseline
Time Frame
6 months
Title
Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status
Description
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.
Time Frame
3 months
Title
Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status
Description
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.
Time Frame
6 months
Title
Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status
Description
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.
Time Frame
3 months
Title
Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status
Description
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.
Time Frame
6 months
Title
Change in periodontal microbiological pathogens.
Description
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.
Time Frame
3 months
Title
Change in periodontal microbiological pathogens.
Description
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.
Time Frame
6 months
Title
Improvement in oral-related quality of life.
Description
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'.
Time Frame
3 months
Title
Improvement in oral-related quality of life.
Description
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'.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikko Kylmänen
Phone
+358407245934
Email
mikko.kylmanen@koitehealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommi Pätilä, Docent
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Timo Sorsa, Professor
Organizational Affiliation
University of Helsinki
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mehiläinen Länsi-Pohja Central Hospital
City
Kemi
State/Province
Lappi
ZIP/Postal Code
94100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikko Kylmänen
First Name & Middle Initial & Last Name & Degree
Timo Sorsa, Professor
First Name & Middle Initial & Last Name & Degree
Paula Tegelberg, DDS
Facility Name
Hammas Hohde Oy
City
Oulu
State/Province
Oulun Lääni
ZIP/Postal Code
90230
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikko Kylmänen
First Name & Middle Initial & Last Name & Degree
Timo Sorsa, Professor
First Name & Middle Initial & Last Name & Degree
Meeri Ojala, DDS
Facility Name
Terveystalo
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Individual Site Status
Withdrawn
Facility Name
City of Rovaniemi Health Cervices, Oral Health
City
Rovaniemi
ZIP/Postal Code
96100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikko Kylmänen
First Name & Middle Initial & Last Name & Degree
Merja Ylipalosaari, Doctor
First Name & Middle Initial & Last Name & Degree
Timo Sorsa, Professor

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://link.springer.com/article/10.1007/s41547-019-00056-9
Description
Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review.
URL
https://pubmed.ncbi.nlm.nih.gov/31783161/
Description
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.
URL
https://pubmed.ncbi.nlm.nih.gov/25261053/
Description
Kassebaum NJ, Bernabé E, Dahiya M et al., (2014) Global burden of severe periodontitis in 1990- 2010: a systematic review and meta-regression.
URL
https://pubmed.ncbi.nlm.nih.gov/28792274/
Description
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
URL
https://pubmed.ncbi.nlm.nih.gov/25496279/
Description
Lang NP, Suvan JE, Tonetti MS (2015) Risk factor assessment tools for the prevention of periodontitis progression a systematic review.
URL
https://www.fda.gov/media/75892/download
Description
Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670400/
Description
Loos BG & Needleman I (2020) Endpoints of active periodontal therapy.
URL
https://www.mdpi.com/1467-3045/44/3/85
Description
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.
URL
https://pubmed.ncbi.nlm.nih.gov/26921460/
Description
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.
URL
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0232775
Description
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.
URL
https://www.mdpi.com/2304-6767/9/5/52
Description
Nikinmaa S, Moilanen N, Sorsa T, et al. (2021a). Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque.
URL
https://www.mdpi.com/2079-6382/10/10/1240
Description
Nikinmaa S, Podonyi A, Raivio P, et al. (2021b). Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus.
URL
https://pubmed.ncbi.nlm.nih.gov/28259623/
Description
Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease.
URL
https://pubmed.ncbi.nlm.nih.gov/32383274/
Description
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.
URL
https://doi.org/10.1016/j.pdpdt.2020.101971
Description
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.
URL
https://pubmed.ncbi.nlm.nih.gov/9332805/
Description
Slade GD (1997) Derivation and validation of a short-form oral health impact profile

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Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis

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