Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 29, 2025

Primary Completion Date

October 31, 2026

Study Completion Date

February 28, 2027

Conditions
Peri-implant Mucositis
Interventions
OTHER

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.

DEVICE

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.

Trial Locations (1)

00161

RECRUITING

Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,, Roma

All Listed Sponsors
collaborator

University of Roma La Sapienza

OTHER

lead

Koite Health Oy

INDUSTRY