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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-02

Study Completion Date

2023-08-11

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.

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

an open-label, single-arm clinical study comparing pre- and post-treatment effects

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

an open-label, single-arm clinical study comparing pre- and post-treatment effects

Study Groups

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35kDa hyaluronan fragment HA35 injection

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

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.

Intervention Type DRUG

Other Intervention Names

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HA35

Eligibility Criteria

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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.

Minimum Eligible Age

32 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No