Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis

NCT05812300 | Completed

• 1 other identifier: HSHN003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

HA35 local injection of Periodontal Pocket group

EXPERIMENTAL

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.

Drug: Freshly manufactured 35 kDa hyaluronan fragment

Interventions

Freshly manufactured 35 kDa hyaluronan fragment 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.

Also known as: HA35

HA35 local injection of Periodontal Pocket group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dove Medical Press Ltd: lead

Study Sites (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, China

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 13, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 20, 2024
• Last Updated: April 25, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)