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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Device: Er: YSGG laser
* Other: no therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two group control and test group test group divided into four subgroups
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Er: YSGG laser therapy, Peri-Implantitis