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

Not Applicable

Completed

• Conditions: Peri-Implantitis
• Interventions: Other: no therapy

• Registration Number: NCT05137821
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-30
• Study Start: 2023-08-10
• Status Verified: 2023-11
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-15
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Sex: female or male.
• Age: 25 - 55 years.
• Medically controlled according to medical coding of review of systems (ROS)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non tested comparative group	no therapy	two sealed new implants as a control

Primary Outcome Measures

Name	Time	Method
visual inspection of the oral biofilm removal efficacy by image analysis software (Adobe Photoshop	2 weeks	evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in; various peri-implant defect morphology

Secondary Outcome Measures

Name	Time	Method
Profilometer analysis of surface roughness changes	1 month	assess the morphological changes of implant surface after Er: YSGG laser therapy through Profilometer analysis

Trial Locations

Locations (1)

Ain Shams Dental School; 🇪🇬 Cairo, Egypt