HA35 Treatment the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis

Dove Medical Press Ltd20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Periodontitis

Interventions

HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)DRUG

The clinical effects of gingival discomfort oritching, redness and swelling, and bleeding from the probing were observed and recorded in patients before and after 7 days of treatment.

Eligibility

Sex: ALLMin age: 32 YearsMax age: 62 Years

Medical Language ↔ Plain English

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.

Locations (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, China

Outcomes

Primary Outcomes

Gingival discomfort scores

This study used a modified pain scale to assess gingival discomfort or itching relief. This quantitative assessment represents the degrees of relief of gingival discomfort. Each patient rated their gingival discomfort or itching on a scale of 0 to 10. 0 means "no gingival discomfort or itching" and 10 means "worst gingival discomfort or itching". Pain intensity levels were assessed before and after 7 days of treatment.

Time frame: 7 days

Secondary Outcomes

The scores of reduction in the extent of gingival redness and swelling and the reduction in gingival bleeding.

Measurement of gum redness and swelling The physician used the numbers 0-10 to rate the intensity of gingival redness and swelling in the subject. 0 means "no gingival redness and swelling"; 10 means "highest intensity of gingival redness and swelling", which is the state of gingival redness and swelling before treatment.

Time frame: 7 days

The scores of reduction in gingival bleeding.

Measurement of probe gingival bleeding The physician used the numbers 0-10 to rate the extent to which the subject's probe gums were bleeding. 0 indicating "no gingival bleeding" and 10 indicating "most gingival bleeding from the probe", which is the pre-treatment state.

Time frame: 7 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.