Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis

NCT ID: NCT05812300

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-02-20

Brief Summary

Preliminary clinical studies have confirmed that injection of freshly prepared HA35 can reduce symptoms and signs of gingivitis or periodontitis. This clinical study is a prospective repeated experiments. The purpose of this study was to verify the effectiveness of HA35 injection therapy.

Detailed Description

The previous studies showed that toothpastes containing the cosmetic grade raw material of the 35 kDa low molecular hyaluronan fragment HA35 significantly reduced symptoms and signs of gingivitis or periodontitis. In this study, patients with mild to moderate periodontitis suffering from symptoms and signs, including discomfort and swelling and bleeding of periodontal tissue, were treated by intrapocket injection of freshly manufactured hyaluronan fragment HA35. This study is an repeat clinical study comparing pre- and posttreatment effects similar to others.

Conditions

Periodontitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HA35 local injection of Periodontal Pocket group

The 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.

Group Type: EXPERIMENTAL

Freshly manufactured 35 kDa hyaluronan fragment

Intervention Type: DRUG

The study was an open-label clinical trial. A pre- and posttreatment controlled study approach was used, whereby the investigator injected 35 kDa hyaluronan fragment HA35 into the periodontal pocket in a single dose of 100 mg. The distribution of the injection amount was determined by the location of gingival inflammation.

Interventions

Freshly manufactured 35 kDa hyaluronan fragment

The study was an open-label clinical trial. A pre- and posttreatment controlled study approach was used, whereby the investigator injected 35 kDa hyaluronan fragment HA35 into the periodontal pocket in a single dose of 100 mg. The distribution of the injection amount was determined by the location of gingival inflammation.

Intervention Type: DRUG

Other Intervention Names

HA35

Eligibility Criteria

Inclusion Criteria

• Healthy condition and with a clinical diagnosis of mild to moderate gingivitis.
• Male or female volunteers aged 18-60 years.
• Gingival Index (GI) from 1 to 2 (0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing)

Exclusion Criteria

• Healthy condition and with a clinical diagnosis of severe gingivitis.
• Pregnant or lactating females.
• Be concomitantly participating in another clinical study.
• History of any allergic reaction to HA.
• To treat the gingivitis with any other medication/mouthwashes in the period of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dove Medical Press Ltd

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huinuode Biotechnology Co., Ltd.

Qingdao, , China

Countries

China

Other Identifiers

HSHN003

Identifier Type: -

Identifier Source: org_study_id