Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis

NCT05278416 | Completed

• 1 other identifier: KHE2021Metro (HOPE-CP)
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients.

Conditions

Periodontitis

Keywords

Lumoral; Lumorinse; Periodontitis; Anti-bacterial photodynamic therapy; aPDT; Plaque; aMMP-8

Outcome Measures

Primary Outcomes (1)

• Bleeding on Probing (BOP)

  Clinical change concerning bleeding on probing change. 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 Outcomes (8)

• Clinical Attachment Level (CAL)

  6 months

• Periodontal Pocket Depth (PPD)

  6 months

• Device-related adverse events

  6 months

• Inflammation marker aMMP-8 measurement

  6 months

• Visual Plaque Index (VPI)

  6 months

Study Arms (2)

Lumoral treatment -device and Lumorinse tablets

ACTIVE COMPARATOR

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 once a day.

Device: Lumoral treatment -device and Lumorinse tablets

Standard of Care

NO INTERVENTION

Subjects will receive oral hygiene instructions for the sonic toothbrushing and the use of interdental cleaning devices. They will not receive an additional intervention.

Interventions

Lumoral treatment -device and Lumorinse tablets DEVICE

Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol.

Lumoral treatment -device and Lumorinse tablets

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Agreement to participate in the study and to sign a written consent form

You may not qualify if:

• Untreated/uncontrollable diabetes mellitus (DM) with HbA1c \>7%, and HbA1c \> 8 if insulin treated DM
• Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
• Use of medicine that would affect the periodontal tissue within the last 6 months (antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers, including doxycycline, bisphosphonates and chlorhexidine)
• Periodontal treatment during the previous 3 months
• Allergic to the photosensitizer
• Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
• Removable major prosthesis or major orthodontic appliance
• Active smoking, or habitual use of smokeless tobacco products
• Pregnancy or lactation
• A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment

Sponsors & Collaborators

• Koite Health Oy: lead
• University of Helsinki: collaborator
• Metropolia University of Applied Sciences: collaborator

Study Sites (1)

Metropolia University of applied sciences

Helsinki, Finland

Location

MeSH Terms

Conditions

Periodontitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Timo Sorsa, Professor

  Univeristy of Helsinki

  PRINCIPAL INVESTIGATOR

• Tommi Pätilä, Docent

  Koite Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 14, 2022
• Study Start: February 8, 2022
• Primary Completion: April 14, 2025
• Study Completion: April 29, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)