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

• Sponsor: Koite Health Oy (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05278416
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 45.7
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Device: Lumoral treatment -device and Lumorinse tablets	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis.
• Actual Study Start Date: Feb 8, 2022
• Anticipated Primary Completion Date: Nov 30, 2025
• Anticipated Study Completion Date: Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lumoral treatment -device and Lumorinse tablets 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; Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol.
No Intervention: Standard of Care Subjects will receive oral hygiene instructions for the sonic toothbrushing and the use of interdental cleaning devices. They will not receive an additional intervention.

Outcome Measures

Primary Outcome Measures

1. Plaque index [6 months]

   Plaque measurement

2. Bleeding [6 months]

   Clinical change concerning bleeding on probing change

3. pocket depth [6 months]

   measurement of pocket depth

4. Clinical attachment level [6 months]

   observation of clinical attachment

Secondary Outcome Measures

1. Change in clinical parameters [6 months]

   Change in aMMP8-measurement reflecting the reduction in periodontitis grade.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Metropolia University of applied sciences	Helsinki		Finland

Sponsors and Collaborators

• Koite Health Oy

Investigators

• Principal Investigator: Timo Sorsa, Univeristy of Helsinki

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Koite Health Oy
• ClinicalTrials.gov Identifier: NCT05278416
• Other Study ID Numbers: KHE2021Metro
• First Posted: Mar 14, 2022
• Last Update Posted: Mar 14, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis; Chronic Periodontitis

Study Results

No Results Posted as of Mar 14, 2022