NCT05812300

Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis

The Clinical Study of Injection of Freshly Prepared HA35 for Treatment Gingivitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Dove Medical Press Ltd · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-01-01
• Completion: 2024-02-20
• First posted: 2023-04-13
• Last updated: 2024-04-25

Locations

1 site across 1 country: China