Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Drug: Freshly manufactured 35 kDa hyaluronan fragment

• Registration Number: NCT05812300
• Lead Sponsor: Dove Medical Press Ltd

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-13
• Study Start: 2023-06-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-20
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HA35 local injection of Periodontal Pocket group	Freshly manufactured 35 kDa hyaluronan fragment	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.

Primary Outcome Measures

Name	Time	Method
Measurement of gum discomfort	7 days	Each patient rated their gingival discomfort or itching on a scale of 0 to 10. 0 means "no", and 10 means "the most".
Measurement of gum redness and swelling	7 days	The physician used the numbers 0-10 to rate the intensity of gingival redness and swelling in the subject. 0 means "no"; 10 means "highest".
Measurement of probe gingival bleeding	7 days	The physician used the numbers 0-10 to rate the extent to which the subject's probe gums were bleeding. A score of 0 indicated "no" and 10 indicated "the most"

Trial Locations

Locations (1)

Huinuode Biotechnology Co., Ltd.; 🇨🇳 Qingdao, China