30
Participants
Start Date
April 29, 2025
Primary Completion Date
October 31, 2026
Study Completion Date
February 28, 2027
Standard oral hygiene
Standard protocol includes oral hygiene instructions (OHI), professional supragingival and subgingival instrumentation, and air polishing. A combination of manual tools (scalers/curettes) and electric tools (sonic/ultrasonic instruments) will be used to remove plaque and tartar, with particular attention to avoid damaging the implant surface. Both supragingival and subgingival surfaces will be treated with the air polishing device using glycine powder. A local antiseptic (1% chlorhexidine gel) will be prescribed twice daily for 7 days after TNC. OHI will be reinforced at each follow-up visit.
The addition of home-based dual-light photodynamic therapy (Lumorinse® + Lumoral®)
Lumorinse® is an effervescent tablet that provides a final concentration of indocyanine green (ICG) of 250 μg/mL when dissolved in 30 mL of water. After rinsing the mouth for 1 minute, the Lumoral® device is used to activate the ICG. The device consists of 48 LED lights in the shape of a mouthguard, which simultaneously provide antibacterial blue light (aBL) at 405 nm and near-infrared (NIR) LED light at 810 nm. In combination with the ICG photosensitizer, the device delivers simultaneous aBL and aPDT action on dental plaque. After 10 minutes of use (30 J/cm2 radiant exposure), the device automatically shuts off. After treatment, patients will follow regular home oral hygiene procedures according to the OHI provided.
RECRUITING
Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,, Roma
University of Roma La Sapienza
OTHER
Koite Health Oy
INDUSTRY