Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05812300
• Other study ID #: HSHN003
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: March 2023
• Source: Dove Medical Press Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 20, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
China	Huinuode Biotechnology Co., Ltd.	Qingdao

Sponsors (1)

Lead Sponsor	Collaborator
Dove Medical Press Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of gum discomfort	Each patient rated their gingival discomfort or itching on a scale of 0 to 10. 0 means "no", and 10 means "the most".	7 days
Primary	Measurement of gum redness and swelling	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".	7 days
Primary	Measurement of probe gingival bleeding	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"	7 days