The Clinical Study of Injection of Freshly Prepared HA35 for Treatment Gingivitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dove Medical Press Ltd
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Measurement of gum discomfort
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Freshly manufactured 35 kDa hyaluronan fragment (Drug)
Outcomes
Primary Outcomes
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".
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".
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"
Secondary Outcomes
No secondary outcomes reported