Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT03153995
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander: A Randomized Controlled Clinical and Histological Study
Status:
COMPLETED
Status Verified Date:
2020-11
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 objective of this study will be to assess and compare between sub-periosteal self- inflating osmotic tissue expanders used as preparatory surgery before alveolar ridge augmentation and periosteal releasing incision using autogenous onlay block bone graft.
The assessment and comparison will be based on:
1. Change in edentulous alveolar ridge in bucco-lingual dimension after alveolar
ridge augmentation.
2. Quantity of the soft tissue obtained after soft tissue expansion.
The assessment and comparison will be based on:
1. Change in edentulous alveolar ridge in bucco-lingual dimension after alveolar
ridge augmentation.
2. Quantity of the soft tissue obtained after soft tissue expansion.
Detailed Description:
* Sixteen patients will be selected from the outpatient clinic of the department of, Oral medicine Periodontology, and oral diagnosis, Faculty of Dentistry, Ain Shams University.
* Three surgeries will be carried out for group I patient; the first is placement of soft tissue expander, the second surgery is bone grafting and placement of collagen membrane for ridge augmentation while the third (re-entry surgery) is implant placement in a routine fashion.
two surgeries will be carried out for group II patient; the first is surgery is bone grafting for ridge augmentation while the second (re-entry surgery) is implant placement in a routine fashion.
-Measurements and evaluation of edentulous ridge will be done by CBCT
* Three surgeries will be carried out for group I patient; the first is placement of soft tissue expander, the second surgery is bone grafting and placement of collagen membrane for ridge augmentation while the third (re-entry surgery) is implant placement in a routine fashion.
two surgeries will be carried out for group II patient; the first is surgery is bone grafting for ridge augmentation while the second (re-entry surgery) is implant placement in a routine fashion.
-Measurements and evaluation of edentulous ridge will be done by CBCT
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?: