NCT05825742

Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment

Efficacy of Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment - Randomized, Controlled Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Koite Health Oy · Industry
• Sex: All
• Age: 15 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine the efficacy of the Lumoral method on oral health in adolescents undergoing fixed orthodontic treatment. 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.

Detailed description

Orthodontic treatment is one of the most common dental treatments in children and adolescents. The use of fixed orthodontic appliances makes it difficult for the patients to keep their oral hygiene to an optimum level of cleanliness. Poor oral hygiene attracts significant plaque accumulation around the fixed orthodontic treatment appliances, and subsequent white spot lesions can occur rapidly, usually on the cervical and middle third of the buccal surfaces of bracketed teeth. Patients with the fixed orthodontic treatment appliances have an increased risk of caries and gingivitis. 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 (aPDT). 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. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. Forty (40) subjects undergoing fixed orthodontic treatment are randomized to the Lumoral treatment group or the control group. All subjects shall receive polishing and oral hygiene instruction. All patients shall be assessed for the clinical measurements including visible plaque index (VPI), bleeding on probing (BOP), and orthodontic plaque index (OPI) at baseline and at 4 weeks and 12 weeks after baseline. In addition, microbiological analyses shall be performed at baseline and at 12 weeks after baseline.

Conditions

• Orthodontic Appliance Complication
• Plaque, Dental
• Gingival Inflammation

Interventions

Type	Name	Description
DEVICE	Lumoral Treatment	Subjects will receive detailed instructions for the use of Lumoral treatment -device. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day for two months and to keep a diary.
OTHER	Standard oral health instructions	Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

Timeline

• Start date: 2023-09-05
• Primary completion: 2025-01-20
• Completion: 2025-03-05
• First posted: 2023-04-24
• Last updated: 2026-01-21

Locations

1 site across 1 country: Sweden