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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild periodontitis and associated with gingival discomfort or itchiness. Patient > 18 years old. Systemically healthy individuals Exclusion Criteria: Patients who take Anticoagulants or Antiplatelet Agents Pregnant or breastfeeding women Patient having expressed his opposition to participate in the research.

Ages Eligible for Study
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Minimum Age: 32 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: an open-label, single-arm clinical study comparing pre- and post-treatment effects
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 35kDa hyaluronan fragment HA35 injection<br>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. | Drug: HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)<br>* 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.<br>* Other names: HA35;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingival redness and bleeding, 35 kDa low molecular hyaluronan fragment, HA35, Tissue permeability, Intra-pocket injection