Clinical trial NCT05765513: HA35 Treatment the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: 35 kDa low molecular hyaluronan fragment
HA35
Tissue permeability
Intra-pocket injection
Gingival redness and bleeding
Lead sponsor: Dove Medical Press Ltd
Sponsor class: NETWORK
First posted: 2023-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 32
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: an open-label, single-arm clinical study comparing pre- and post-treatment effects
Primary purpose: TREATMENT

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 47±15 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.

Eligibility criteria: Inclusion Criteria:

1. Mild periodontitis and associated with gingival discomfort or itchiness.
2. Patient \> 18 years old.
3. Systemically healthy individuals

Exclusion Criteria:

1. Patients who take Anticoagulants or Antiplatelet Agents
2. Pregnant or breastfeeding women
3. Patient having expressed his opposition to participate in the research.

Primary outcomes:
measure: Gingival discomfort scores
timeFrame: 7 days
Secondary outcomes:
measure: The scores of reduction in the extent of gingival redness and swelling and the reduction in gingival bleeding.
timeFrame: 7 days
measure: The scores of reduction in gingival bleeding.
timeFrame: 7 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Huinuode Biotechnology Co., Ltd.
Study officials:
References:
citation: APPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286
citation: Jia X, Shi M, Wang Q, Hui J, Shofaro JH, Erkhembayar R, Hui M, Gao C, Gantumur MA. Anti-Inflammatory Effects of the 35kDa Hyaluronic Acid Fragment (B-HA/HA35). J Inflamm Res. 2023 Jan 13;16:209-224. doi: 10.2147/JIR.S393495. eCollection 2023.