Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540690
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients Controlled Clinical Trial and in Vitro Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients evaluate clinical patient-centered and immunological parameters as well as wound microbiome composition
Detailed Description:
The use of autogenous grafts from the palate for the reconstruction of gingival tissues is considered the gold standard for various periodontal and peri-implant reconstructions Given the current aging of the population it is essential to understand the cellular mechanisms responsible for the repair response in oral tissues and how they are affected by systemic diseases such as diabetes mellitus DM The objectives of the present study conducted through a controlled clinical trial are to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients This will be achieved through clinical analyses patient-centered parameters inflammatory biomarkers and wound microbiome composition To accomplish this 50 patients will be divided into two groups the Diabetic Group D n 25 where diabetic patients will undergo surgery for mucogingival defect correction with the addition of a free gingival graft and the Control Group GC n 25 where normoglycemic patients will undergo surgery for mucogingival defect correction with the addition of a free gingival graft The groups will be compared regarding clinical parameters patient-centered measures including remaining wound area epithelialization tissue thickness immature wound area tissue edema early wound healing index postoperative discomfort quality of life number of analgesics and sensitivity of the operated area over a 3-month period Furthermore the wound biofilm will be described through microbiome analysis and tissue saliva and wound exudate biomarkers will be characterized Descriptive statistics will be expressed as mean standard deviation clinical evaluations will be performed using repeated measures ANOVA and patient-centered parameters will be assessed using the T-test Finally multiple linear regression and correlation tests will be employed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None