Periodontitis
Conditions
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.
Interventions
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.
Sponsors
Dove Medical Press Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of gum discomfort | 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 | 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 | 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 |
Countries
China
Outcome results
None listed