NCT05252000

Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare clinical outcomes after mechanical debridement of at sites exhibiting plaque induced inflammation with or without adjunctive Antimicrobial photodynamic therapy (aPDT) and to assess the the microbiologic profile before and after treatment with or without aPDT

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
DEVICE	mechanical debridement	subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque
DEVICE	adjunctive aPDT	Antimicrobial photodynamic therapy will be done at tooth sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. After 3 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the tooth using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
DEVICE	sham aPDT	subjects will receive saline and non-light emitting laser on the tooth

Timeline

• Start date: 2022-04-26
• Primary completion: 2023-10-10
• Completion: 2023-10-10
• First posted: 2022-02-23
• Last updated: 2026-03-12
• Results posted: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study