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

Peri-Implantitis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05137821
• Other study ID #: FDASU-REC ID210314
• Status: Completed
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: November 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 15, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• Sex: female or male.

• Age: 25 - 55 years.

• Medically controlled according to medical coding of review of systems (ROS)

Exclusion Criteria:

• Tobacco smoking for at least 6 months before the study enrollment

• Participants with ill-fitting restorations in both upper first molars that affect the stability of the stent.

• Participants not following oral hygiene instructions.

• Participants on dental treatment during the study period.

• Participants with a history of drug administration

• Vulnerable group.

• Participants with long-term mouthwash administration.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams Dental School	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	biocompatibility test of the surface	assess the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs)	2 months
Primary	visual inspection of the oral biofilm removal efficacy by image analysis software (Adobe Photoshop	evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in; various peri-implant defect morphology	2 weeks
Secondary	Profilometer analysis of surface roughness changes	assess the morphological changes of implant surface after Er: YSGG laser therapy through Profilometer analysis	1 month