NCT04187053

Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation

Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical Treatment of Peri-implant Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (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 (change in bleeding sites (BOP) and probing depth reduction (PPD) after mechanical debridement of implant surfaces at sites exhibiting plaque induced inflammation with or without adjunctive antimicrobial photodynamic therapy (aPDT) and assess the microbiologic profile of plaque samples before and after treatment with or without aPDT samples.

Conditions

• DENT IMPLANTS
• LASER

Interventions

Type	Name	Description
PROCEDURE	Conventional mechanical therapy	Both experimental and sham arms will receive the Conventional mechanical therapy
DRUG	Saline	Sham group will receive saline as a sham for methylene blue
DRUG	Methylene Blue	Experimental arm will receive methylene blue
DEVICE	Light emitting laser	Experimental arm will receive Light emitting laser
DEVICE	Non-light emitting laser	Sham group will receive Non-light emitting laser

Timeline

• Start date: 2020-02-14
• Primary completion: 2022-12-06
• Completion: 2022-12-06
• First posted: 2019-12-05
• Last updated: 2024-02-21
• Results posted: 2023-12-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study