Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis

Dove Medical Press

Status: Completed

Conditions: Periodontitis

Treatments: Drug: Freshly manufactured 35 kDa hyaluronan fragment

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05812300

HSHN003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

HA35 local injection of Periodontal Pocket group

Experimental group

Description:

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.

Treatment:

Drug: Freshly manufactured 35 kDa hyaluronan fragment