Back to resultsLocal Injection of Periodontal Pocket Method for the Treatment of Gingivitis
Primary Purpose
Periodontitis
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Freshly manufactured 35 kDa hyaluronan fragment
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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.
Sites / Locations
- Huinuode Biotechnology Co., Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HA35 local injection of Periodontal Pocket group
Arm Description
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.
Outcomes
Primary Outcome Measures
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".
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".
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"
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05812300
Brief Title
Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis
Official Title
The Clinical Study of Injection of Freshly Prepared HA35 for Treatment Gingivitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dove Medical Press Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HA35 local injection of Periodontal Pocket group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Freshly manufactured 35 kDa hyaluronan fragment
Other Intervention Name(s)
HA35
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of gum discomfort
Description
Each patient rated their gingival discomfort or itching on a scale of 0 to 10. 0 means "no", and 10 means "the most".
Time Frame
7 days
Title
Measurement of gum redness and swelling
Description
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".
Time Frame
7 days
Title
Measurement of probe gingival bleeding
Description
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"
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Huinuode Biotechnology Co., Ltd.
City
Qingdao
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data will be sent to the accepting journal study.
Learn more about this trial
Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis
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