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

Periodontitis Clinical Trial

— HOPE-CP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278416
• Other study ID #: KHE2021Metro (HOPE-CP)
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: February 2024
• Source: Koite Health Oy
• Contact: Mikko Kylmänen
• Phone: +358407245934
• Email: mikko.kylmanen[@]koitehealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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. The device is used by swishing a mouth rinse, strongly adhering to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in long-term use. 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 subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Finland	Metropolia University of applied sciences	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Koite Health Oy	University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque index	Plaque measurement	6 months
Primary	Bleeding	Clinical change concerning bleeding on probing change	6 months
Primary	pocket depth	measurement of pocket depth	6 months
Primary	Clinical attachment level	observation of clinical attachment	6 months
Secondary	Change in clinical parameters	Change in aMMP8-measurement reflecting the reduction in periodontitis grade.	6 months