Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis

Koite Health

Status: Completed

Conditions: Periodontitis; Plaque Induced Gingivitis; Periodontal Diseases; Plaque, Dental

Treatments: Device: Lumoral treatment; Other: Standard oral hygiene self care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05425784

LumoNorth2022

Details and patient eligibility

About

This early-stage research is designed to determine the efficacy of the Lumoral method in chronic 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.

Full description

Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque.

The Lumoral 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, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.

Enrollment: 41 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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, including implants
• Agreement to participate in the study and to sign a written consent form
• Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol

Exclusion criteria

• Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
• Removable major prosthesis or major orthodontic appliance
• Pregnancy or lactation
• Use of antibiotics within 2 weeks prior the study
• A need for immediate antimicrobial treatment for periodontitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

41 participants in 2 patient groups

Lumoral Treatment (Study group)

Experimental group

Description:

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 five to seven (5-7) times a week. Regular use shall be defined as frequency of a minimum of twice a week. Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects.

Treatment:

Other: Standard oral hygiene self care

Device: Lumoral treatment

Standard of care (Control group)

Active Comparator group

Description:

Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects.

Treatment:

Other: Standard oral hygiene self care