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NCT Number: NCT05137821

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

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.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams Dental School

Cairo, 11411, Egypt

About this 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Er: YSGG laser

Device

Er: YSGG laser decontamination of infected implant surfaces to simulate peri-implantitis therapy

no therapy

Other

new sealed implant without any surface treatment

Primary outcomes

  1. visual inspection of the oral biofilm removal efficacy by image analysis software (Adobe Photoshop

    Time frame: 2 weeks

    evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in

    various peri-implant defect morphology

Secondary outcomes

  1. Profilometer analysis of surface roughness changes

    Time frame: 1 month

    assess the morphological changes of implant surface after Er: YSGG laser therapy through Profilometer analysis

Other outcomes

  1. biocompatibility test of the surface

    Time frame: 2 months

    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)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2021
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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