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

September 16, 2023 updated by: Koite Health Oy
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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
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.
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.
Other Names:
  • Lumorinse mouth rinse
Experimental: Study group
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.
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.
Other Names:
  • Lumorinse mouth rinse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BoP
Time Frame: 4 weeks

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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological pathogens
Time Frame: 4 weeks

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.

4 weeks
aMMP-8
Time Frame: 4 weeks
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.
4 weeks
VPI
Time Frame: 4 weeks

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
4 weeks
PPD
Time Frame: 4 weeks

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).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Tommi Pätilä, Docent, Head of Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Actual)

August 16, 2023

Study Completion (Actual)

August 16, 2023

Study Registration Dates

First Submitted

April 29, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will only be administered by the researchers that are listed in the CIP.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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