Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT00731432
Status:
SUSPENDED
Last Update Posted:
2011-07-20
First Post:
2008-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics
Sponsor:
Izun Pharma Ltd
Organization:
Study Overview
Official Title:
The Effect Of A Transmucosal Herbal Periodontal Patch (THPP) on Gingival Inflammation in Diabetic Patients
Status:
SUSPENDED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to recruit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetes increases the incidence and severity of periodontal inflammation and disease, and periodontal disease causes an increase in the severity of diabetes by worsening glycemic control and increasing insulin resistance.The Transmucosal Herbal Periodontal Patch (THPP) is a transmucosal patch containing an herbal compound that has an anti-inflammatory effect on gingival tissue.The primary objective of this study is to determine the efficacy of the Transmucosal Herbal Periodontal Patch (THPP) compared with placebo patch (PP) in reducing gingival inflammation at the site of placement in diabetic patients. We also aim to determine if the THPP decreases gingival inflammation throughout the mouth and the safety of THPP compared with placebo patch when applied to the mucosa in the treatment of gingival inflammation in diabetic patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: