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)

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.

Study Overview

• Status: Completed
• Conditions: Peri-Implantitis
• Intervention / Treatment: Other: no therapy; Device: Er: YSGG laser

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11411
    • Ain Shams Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non tested comparative group; two sealed new implants as a control	Other: no therapy; new sealed implant without any surface treatment
Experimental: Er: YSGG laser tested group; 24 infected implants divided into four subgroups that will be decontaminated by Er: YSGG laser in various peri-implant defects	Device: Er: YSGG laser; Er: YSGG laser decontamination of infected implant surfaces to simulate peri-implantitis therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profilometer analysis of surface roughness changes	assess the morphological changes of implant surface after Er: YSGG laser therapy through Profilometer analysis	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Peri-Implantitis; Er: YSGG laser therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: FDASU-REC ID210314

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes