Clinical trial NCT05137821: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Keywords: Er: YSGG laser therapy
Peri-Implantitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 3
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two group control and test group test group divided into four subgroups
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: visual inspection of the oral biofilm removal efficacy by image analysis software (Adobe Photoshop
timeFrame: 2 weeks
Secondary outcomes:
measure: Profilometer analysis of surface roughness changes
timeFrame: 1 month
Other outcomes:
measure: biocompatibility test of the surface
timeFrame: 2 months
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Dental School
Study officials:
References: