NCT05137821

Efficacy of Er: YSGG Laser in Treatment of Peri-implantitis

Efficacy of Er: YSGG Laser on Oral Biofilm Removal From Implant Surface and Its Biological Response to Periodontal Tissues in Treatment of Peri-implantitis (An Ex Vivo Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective. To assess the morphological changes and the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.

Detailed description

This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective. To assess the morphological changes and the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives. The study was designed as an Ex Vivo study. Four periodontally and systemically healthy volunteers of both gender are included in this study for the formation of in vivo plaque biofilm. Each volunteer will wear a hard resin splint carrying six rough (machined implant; 3.3mm diameter, 8mm length) for 4 days to accumulate dental plaque naturally on the titanium surfaces of the implants. Therefore, 24 implants will be assessed for Er: YSGG laser therapy in different bone defect simulators.

Conditions

• Peri-Implantitis

Interventions

Type	Name	Description
DEVICE	Er: YSGG laser	Er: YSGG laser decontamination of infected implant surfaces to simulate peri-implantitis therapy
OTHER	no therapy	new sealed implant without any surface treatment

Timeline

• Start date: 2023-08-10
• Primary completion: 2023-11-01
• Completion: 2023-11-15
• First posted: 2021-11-30
• Last updated: 2023-11-21

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study