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

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Description

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

Targeted Conditions

Study Overview

Start Date
February 8, 2022
Completion Date
November 30, 2025
Enrollment
200
Date Posted
March 14, 2022
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
Metropolia University of applied sciences
Helsinki, Finland

Eligibility

Minimum Age (years)
18
Maximum Age (years)
85
Eligibility Criteria
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

Study Contact Info

Study Contact Name
Mikko Kylmänen
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed 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.
NCTid (if applicable)
NCT05278416