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

Primary Purpose

Peri-Implantitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Er: YSGG laser
no therapy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring Er: YSGG laser therapy, Peri-Implantitis

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    non tested comparative group

    Er: YSGG laser tested group

    Arm Description

    two sealed new implants as a control

    24 infected implants divided into four subgroups that will be decontaminated by Er: YSGG laser in various peri-implant defects

    Outcomes

    Primary Outcome Measures

    visual inspection of the oral biofilm removal efficacy
    evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 1, 2021
    Last Updated
    November 16, 2021
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05137821
    Brief Title
    Efficacy of Er: YSGG Laser in Treatment of Peri-implantitis
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    February 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peri-Implantitis
    Keywords
    Er: YSGG laser therapy, Peri-Implantitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    two group control and test group test group divided into four subgroups
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    4 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    non tested comparative group
    Arm Type
    Experimental
    Arm Description
    two sealed new implants as a control
    Arm Title
    Er: YSGG laser tested group
    Arm Type
    Experimental
    Arm Description
    24 infected implants divided into four subgroups that will be decontaminated by Er: YSGG laser in various peri-implant defects
    Intervention Type
    Device
    Intervention Name(s)
    Er: YSGG laser
    Intervention Description
    Er: YSGG laser decontamination of infected implant surfaces to simulate peri-implantitis therapy
    Intervention Type
    Other
    Intervention Name(s)
    no therapy
    Intervention Description
    new sealed implant without any surface treatment
    Primary Outcome Measure Information:
    Title
    visual inspection of the oral biofilm removal efficacy
    Description
    evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Profilometer analysis of surface roughness changes
    Description
    assess the morphological changes of implant surface after Er: YSGG laser therapy through Profilometer analysis
    Time Frame
    1 month
    Other Pre-specified Outcome Measures:
    Title
    biocompatibility test of the surface
    Description
    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)
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    alaa Hashim, Assistant lecturer
    Phone
    01003942056
    Email
    dralaa89@dent.asu.edu.eg

    12. IPD Sharing Statement

    Learn more about this trial

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

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