Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT05800795
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2023-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray: A Randomized Controlled Clinical Study With Histological, and Scanning Electron Microscopic Analysis
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The attachment of peri implant soft tissue to the implant serves as a biological seal that can prevent the development of inflammatory peri-implant diseases. Presence of contaminants has been suggested to be associated with tissue damaging inflammation and titanium wear microparticles were demonstrated to activate osteoclastic action. Er: YAG laser has been extensively investigated clinically for applications for treating periimplantitis either independently or in combination with other techniques, showing favorable outcomes. Plasma spray treatment can decontaminate surfaces without modifying their topography. It is also able to increase the surface energy by obtaining more hydrophilic surfaces, which may increase the capacity of the titanium oxide layer to interact with cells and proteins of surrounding tissue improving cell adhesion to the treated surface.
Detailed Description:
This study was conducted on 24 patients seeking implant placement. A total number of 33 healing abutments were included in this study, they were divided into 3 groups. Group 1 (Laser group): 8 patients in this group received 11 healing abutments treated with Er:YAG laser, group 2 (Plasma group): 8 patients in this group received 11 healing abutments treated with plasma sprayand group 3 (control group): 8 patients in this group received 11 healing abutments with no surface treatment.Three months after implants placement, patients included in the study were randomly assigned to one of the three study groups, second stage surgery was performed and patients received healing abutments without surface treatment in control group, surface treatment was performed in plasma and laser groups. After two weeks, clinical assessment was done using PI and GI before taking biopsies from peri-implant soft tissue for histological assessment. H\&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction. Analysis of the abutments surface was done using SEM.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: