Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis

March 18, 2026 updated by: Koite Health Oy

This study is designed to determine the efficacy of the Lumoral method in chronic periodontitis with a targeted group of stage III and IV periodontitis.

Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term.

In addition, the method might have a photobiomodulation effect on periodontal tissues.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Lumoral Treatment 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 (aPDT). The device is used by swishing a specially designed mouth rinse that strongly adheres to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown promising anti-inflammatory responses in addition to plaque reduction.

Study Type

Interventional

Enrollment (Actual)

56

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 Locations

  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology

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:

  • Periodontal disease stage III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss.
  • ≥ 18 years old
  • 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:

  • Grade A or C periodontitis
  • Presence of any physical limitation or restriction that might restrict Lumoral use
  • Pregnancy or lactation
  • Active smoking
  • Medicated diabetes mellitus (DM)
  • Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
  • Use of antibiotics within 4 weeks week prior study
  • Periodontal treatment within 3 months prior study
  • Removable major prosthesis or major orthodontic appliance
  • A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group

A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use.

All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.
Device: Lumoral Treatment
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.
No Intervention: Control group
A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing (BOP)
Time Frame: 6 months

Improvement in bleeding on probing (BOP)

  • A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual)
  • 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 is reported as the percentage (%) of sites with positive findings
  • Calculation formula: number of bleeding sites/ 6 times number of teeth
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visible plaque index (VPI)
Time Frame: 6 months
Change in visible plaque index (VPI)
6 months
Probing pocket depth (PPD)
Time Frame: 6 months
Change in probing pocket depth (PPD)
6 months
Clinical attachment level (CAL)
Time Frame: 6 months
Change in clinical attachment level (CAL)
6 months
Periodontal microbiological flora
Time Frame: 6 months
Change in periodontal microbiological flora during the study period
6 months
Additional visits
Time Frame: 6 months
Number of additional visits due to periodontitis status between 2nd and 3rd follow-up visits
6 months
OHIP-14
Time Frame: 6 months
Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire
6 months
Active matrix metalloproteinase 8 (aMMP-8)
Time Frame: 6 months
Change in periodontal inflammation marker aMMP-8
6 months
Deep periodontal pockets (over 4 mm)
Time Frame: 6 months
Change in the number of deep periodontal periodontal pockets (over 4 mm)
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-related adverse event
Time Frame: 6 months
Absence of device-related serious adverse events or any patterns of device-related adverse events graded as moderate
6 months

Collaborators and Investigators

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

Sponsor

Koite Health Oy

Collaborators

Lithuanian University of Health Sciences
University of Helsinki

Investigators

  • Study Director: Timo Sorsa, Professor, University of Helsinki
  • Study Chair: Tommi Pätilä, Docent, Koite Health
  • Principal Investigator: Ingrida Marija Pacauskiene, Doctor, Lithuanian University of Health Sciences

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.

General Publications

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)

June 6, 2023

Primary Completion (Actual)

December 12, 2025

Study Completion (Actual)

January 12, 2026

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LumoKaunas2023

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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