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Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health

Primary Purpose

Periodontitis, Plaque, Dental, Plaque Induced Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Lumoral device
Sponsored by
Koite Health Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Periodontitis focused on measuring Lumoral, Lumorinse, Plaque, Periodontitis, Plaque control

Eligibility Criteria

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

Inclusion Criteria:

  • At least 18 years old
  • Agreement to participate in the study and to sign a written consent form

Exclusion Criteria:

  • Presence of any physical limitation or restriction that might restrict Lumoral use
  • Pregnancy or lactation

Sites / Locations

  • Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm Description

Subjects in the study group will use the Lumoral device once a day according to the verbal and written instructions provided to them. In addition, they will brush their teeth twice daily in their customary manner while using the provided sonic toothbrush and regular toothpaste.

Subjects in the control group will brush their teeth in their customary manner twice daily while using the provided sonic toothbrush and regular toothpaste. They will not receive any additional intervention.

Outcomes

Primary Outcome Measures

BoP
Reduction in bleeding on probing (BoP). Procedure for BoP: A full-mouth assessment at six sites per tooth Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent" BOP reported as the percentage (%) of sites with positive findings Calculation formula: number of bleeding sites/ 6 times number of teeth

Secondary Outcome Measures

Microbiological pathogens
Change in periodontal microbiological pathogens. The plaque sample will be taken from the teeth with ≥3 mm pockets with a sterile paper point. If the subject does not have any deep periodontal pockets, then a sample will be taken from shallow sites. Prior to sampling, the supragingival plaque will be removed with a curette. The paper point will be then taken to the gingival pocket with sterile tweezers. The paper pin will be allowed to stand for 10 to 20 seconds, after which it will be removed and sealed in an empty plastic sample transport tube. A gene amplification method (polymerase chain reaction, PCR) will be used to look for six key bacteria in periodontitis: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia and Parvimonas micra.
aMMP-8
Reduction in periodontal inflammation marker aMMP-8. An aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions.
VPI
Clinical improvement concerning visible plaque index (VPI). Procedure for VPI: A full-mouth assessment, measured at 4 sites per tooth Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent" VPI reported as the percentage (%) of sites with plaque Calculation formula: number of sites with plaque/ 4 times number of teeth
PPD
Reduction in probing pocket depth (PPD). Procedure for PPD: A full-mouth assessment, measured at six sites per tooth Assessed from the base of the pocket to the gingival margin (mm).

Full Information

First Posted
April 29, 2022
Last Updated
September 16, 2023
Sponsor
Koite Health Oy
Collaborators
Tampere University, University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT05361590
Brief Title
Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health
Official Title
Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
August 16, 2023 (Actual)
Study Completion Date
August 16, 2023 (Actual)

3. Sponsor/Collaborators

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

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 study is designed to determine the efficacy of the CE-approved, antibacterial, dual-light Lumoral method in 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
Dental plaque triggers changes in gingival health, which results in slight swelling and bleeding from the gingival margin and causes gingivitis. Supragingival dental biofilm control can be achieved by mechanical and chemical means. Toothbrushing is effective in reducing levels of dental plaque (van der Weijden & Slot 2015). It removes plaque from flat, accessible surfaces but is less effective at the gingival margins and in approximal areas, where the accumulation of residual plaque encourages gingivitis and deterioration of periodontal health. Effective toothbrushing is also depending on a number of factors, e.g., age, knowledge, manual dexterity and motivation. Oral hygiene instructions and patient motivation in oral hygiene practices should be an integral part of the patient management during all stages of periodontal treatment (Tonetti et al., 2015). Oral health practice of individuals affects their gingival and periodontal health. 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. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. This early-stage study is designed to determine the efficacy of the Lumoral method in 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. Forty (40) patients are randomized to the Lumoral treatment group or the control group. Both groups shall receive standard oral hygiene instructions for sonic toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontal status including visible plaque index (VPI), bleeding on probing (BOP) and probing pocket depth (PPD). In addition, aMMP-8 mouth rinse test and microbiological analysis of gingival pockets will be performed. Digital photographs after staining will be taken. These analyses shall be performed at baseline and at 4 weeks after the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Plaque, Dental, Plaque Induced Gingivitis
Keywords
Lumoral, Lumorinse, Plaque, Periodontitis, Plaque control

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
20 participants in the treatment (Lumoral) group and 20 participants in the control group.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The subjects will be randomized into the study group and the control group by using a sealed envelope system.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Subjects in the study group will use the Lumoral device once a day according to the verbal and written instructions provided to them. In addition, they will brush their teeth twice daily in their customary manner while using the provided sonic toothbrush and regular toothpaste.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Subjects in the control group will brush their teeth in their customary manner twice daily while using the provided sonic toothbrush and regular toothpaste. They will not receive any additional intervention.
Intervention Type
Device
Intervention Name(s)
Lumoral device
Other Intervention Name(s)
Lumorinse mouth rinse
Intervention Description
The Lumoral treatment -device is a CE-marked antibacterial home-use device for the treatment and prevention of oral diseases caused by bacteria. It is used in combination with a CE-marked mouth rinse called Lumorinse.
Primary Outcome Measure Information:
Title
BoP
Description
Reduction in bleeding on probing (BoP). Procedure for BoP: A full-mouth assessment at six sites per tooth Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent" BOP reported as the percentage (%) of sites with positive findings Calculation formula: number of bleeding sites/ 6 times number of teeth
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Microbiological pathogens
Description
Change in periodontal microbiological pathogens. The plaque sample will be taken from the teeth with ≥3 mm pockets with a sterile paper point. If the subject does not have any deep periodontal pockets, then a sample will be taken from shallow sites. Prior to sampling, the supragingival plaque will be removed with a curette. The paper point will be then taken to the gingival pocket with sterile tweezers. The paper pin will be allowed to stand for 10 to 20 seconds, after which it will be removed and sealed in an empty plastic sample transport tube. A gene amplification method (polymerase chain reaction, PCR) will be used to look for six key bacteria in periodontitis: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia and Parvimonas micra.
Time Frame
4 weeks
Title
aMMP-8
Description
Reduction in periodontal inflammation marker aMMP-8. An aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions.
Time Frame
4 weeks
Title
VPI
Description
Clinical improvement concerning visible plaque index (VPI). Procedure for VPI: A full-mouth assessment, measured at 4 sites per tooth Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent" VPI reported as the percentage (%) of sites with plaque Calculation formula: number of sites with plaque/ 4 times number of teeth
Time Frame
4 weeks
Title
PPD
Description
Reduction in probing pocket depth (PPD). Procedure for PPD: A full-mouth assessment, measured at six sites per tooth Assessed from the base of the pocket to the gingival margin (mm).
Time Frame
4 weeks

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: At least 18 years old Agreement to participate in the study and to sign a written consent form Exclusion Criteria: Presence of any physical limitation or restriction that might restrict Lumoral use Pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommi Pätilä, Docent
Organizational Affiliation
Head of Research
Official's Role
Study Director
Facility Information:
Facility Name
Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The IPD will only be administered by the researchers that are listed in the CIP.
Links:
URL
https://doi.org/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. Laser Dent Sci 3, 147-153 (2019
URL
https://scirp.org/reference/referencespapers.aspx?referenceid=2467179
Description
Chapple ILC, Mealey BL, Van Dyke TE et al., (2018). Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-
URL
https://www.fda.gov/media/75892/download
Description
Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.
URL
https://doi.org/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. PLoS ONE 15(5): e0232775.
URL
https://researchportal.helsinki.fi/en/publications/repeated-home-applied-dual-light-antibacterial-photodynamic-thera
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://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
http://dx.doi.org/10.1016/j.parkreldis.2017.02.026
Description
Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease. Parkinsonism and Related Disorders 38: 61-67.
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. J Clin Periodontol., 47: 4- 60.
URL
https://pubmed.ncbi.nlm.nih.gov/25639948/
Description
Tonetti MS, Eickholz P, Loos BG et al., (2015). Principles in prevention of periodontal diseases: Consensus report of group 1 of the 11th European Workshop on Periodontology on effective prevention of periodontal and peri-implant diseases. Journal of
URL
https://pubmed.ncbi.nlm.nih.gov/25597787/
Description
Van der Weijden FA & Slot DE (2015). Efficacy of homecare regimens for mechanical plaque removal in managing gingivitis: A metareview. Journal of Clinical Periodontology, 42(Suppl 16), S77-S91
URL
https://doi.org/10.1590/S1806-83242014.50000004
Description
Gomes SC, Romagna R, Rossi V, Corvello PC, Melchiors-Angst PD. Supragingival treatment as an aid to reduce subgingival needs: a 450-day investigation Braz. oral res. 28 (1) (2014)

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Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health

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