NCT05361590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

October 11, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

April 29, 2022

Last Update Submit

September 16, 2023

Conditions

PeriodontitisPlaque, DentalPlaque Induced Gingivitis

Keywords

LumoralLumorinsePlaquePeriodontitisPlaque control

Outcome Measures

Primary Outcomes (1)

  • 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

    4 weeks

Secondary Outcomes (4)

  • Microbiological pathogens

    4 weeks

  • aMMP-8

    4 weeks

  • VPI

    4 weeks

  • PPD

    4 weeks

Study Arms (2)

Study group

EXPERIMENTAL

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.

Device: Lumoral device

Control group

ACTIVE COMPARATOR

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.

Device: Lumoral device

Interventions

Lumoral deviceDEVICE

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.

Also known as: Lumorinse mouth rinse
Control groupStudy group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tampere, Pirkanmaa, 33520, Finland

Location

Related Links

MeSH Terms

Conditions

PeriodontitisDental PlaquePlaque, Amyloid

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Tommi Pätilä, Docent

    Head of Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The subjects will be randomized into the study group and the control group by using a sealed envelope system.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 20 participants in the treatment (Lumoral) group and 20 participants in the control group.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 4, 2022

Study Start

October 11, 2022

Primary Completion

August 16, 2023

Study Completion

August 16, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

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

Locations

FI(1)