Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05765513
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2023-02-22
Brief Title:
HA35 Treatment the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis
Sponsor:
Dove Medical Press Ltd
Organization:
Dove Medical Press Ltd
Study Overview
Official Title:
Intra-pocket Injection of a Freshly Manufactured 35 kDa Hyaluronan Fragment HA35 Reduces the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis A Clinical Study
Status:
COMPLETED
Status Verified Date:
2023-02
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 main objective of this study is to research the treatment of 35 kDa hyaluronan fragment HA35 for Mild periodontitis and associated with gingival discomfort or itchiness
Detailed Description:
In this study tissue permeable 35 kDa low molecular hyaluronan fragment HA35 was freshly manufactured using pharmaceutical grade hyaluronidase PH20 injection State Drug Administration H31022111 and joint cavity HA injection State Drug Administration H20174089 mixed at room temperature for 20 min
In this study 20 patients 8 males and 12 females with a mean age of 4715 years were selected from the outpatient clinic of the Department of Dentistry All had mild periodontitis and were associated with gingival discomfort or itchiness Injection treatment was performed using freshly manufactured 35 kDa hyaluronan fragment HA35 The study was an open-label clinical trial in which no information was withheld from the participating investigators A pre- and post-treatment controlled study approach was used whereby the investigator injected 35kDa hyaluronan fragment HA35 into the periodontal pocket in a single dose of 100 mg The distribution of injection amount was determined by the location of gingival inflammation The clinical effects of gingival discomfort or itching redness and swelling and bleeding from the probing were observed and recorded in patients before and after 7 days of treatment
In this study 20 patients 8 males and 12 females with a mean age of 4715 years were selected from the outpatient clinic of the Department of Dentistry All had mild periodontitis and were associated with gingival discomfort or itchiness Injection treatment was performed using freshly manufactured 35 kDa hyaluronan fragment HA35 The study was an open-label clinical trial in which no information was withheld from the participating investigators A pre- and post-treatment controlled study approach was used whereby the investigator injected 35kDa hyaluronan fragment HA35 into the periodontal pocket in a single dose of 100 mg The distribution of injection amount was determined by the location of gingival inflammation The clinical effects of gingival discomfort or itching redness and swelling and bleeding from the probing were observed and recorded in patients before and after 7 days of treatment
Study Oversight
Has Oversight DMC:
None
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?:
None