Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT05805033
Status:
RECRUITING
Last Update Posted:
2024-09-05
First Post:
2023-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peri-Implant Soft Tissue Integration in Humans: Influence of Material
Sponsor:
Centre Hospitalier Universitaire de Liege
Organization:
Study Overview
Official Title:
Peri-Implant Soft Tissue Integration in Humans: Influence of Material
Status:
RECRUITING
Status Verified Date:
2024-09
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 purpose of this study is to compare the mucointegration of 2 types of surface roughness of zirconia abutments with titanium. The surface roughness will be machined and ultra-polished.
Detailed Description:
After being informed about the study and potential risks, all participants give written informed consent and eligibility for study entry.
The day of the surgery, patients will be randomized in machined zirconia or ultra-polished zirconia.
After 8 weeks of healing, biopsy are separated in two groups according to the removal:
* if the abutment come together with the surrounding soft tissues, it goes for a non decalcified histology for histometric measurements to determine the dimensions of biological width (sulcus depth, epithelial and connective adhesion)
* if the abutment come separate of the surrounding tissue, the soft tissue goes for immunohistochemistry to analyse pro-inflammatory cells and vascularisation and the abutment for SEM analysis to calculate the percentage of adhesion of the cells on the abutment
The day of the surgery, patients will be randomized in machined zirconia or ultra-polished zirconia.
After 8 weeks of healing, biopsy are separated in two groups according to the removal:
* if the abutment come together with the surrounding soft tissues, it goes for a non decalcified histology for histometric measurements to determine the dimensions of biological width (sulcus depth, epithelial and connective adhesion)
* if the abutment come separate of the surrounding tissue, the soft tissue goes for immunohistochemistry to analyse pro-inflammatory cells and vascularisation and the abutment for SEM analysis to calculate the percentage of adhesion of the cells on the abutment
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| B7072022000023 | OTHER | Comité de étique Hospitalo-Facultaire Universitaire de Liege | View |