Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis

April 24, 2024 updated by: Dove Medical Press Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Qingdao, China
        • Huinuode Biotechnology Co., Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HA35 local injection of Periodontal Pocket group
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
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.
Other Names:
  • HA35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of gum discomfort
Time Frame: 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".
7 days
Measurement of gum redness and swelling
Time Frame: 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".
7 days
Measurement of probe gingival bleeding
Time Frame: 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"
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dove Medical Press Ltd

Collaborators

Hainan Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

February 20, 2024

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSHN003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be sent to the accepting journal study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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