Periodontitis
Conditions
Keywords
35 kDa low molecular hyaluronan fragment, HA35, Tissue permeability, Intra-pocket injection, Gingival redness and bleeding
Brief summary
The main objective of this study is to research the treatment of 35 kDa hyaluronan fragment HA35 for Mild periodontitis and associated with gingival discomfort or itchiness.
Detailed description
In this study, 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. In this study, 20 patients, 8 males, and 12 females, with a mean age of 47±15 years, were selected from the outpatient clinic of the Department of Dentistry. All had mild periodontitis and were associated with gingival discomfort or itchiness. Injection treatment was performed using freshly manufactured 35 kDa hyaluronan fragment HA35. The study was an open-label clinical trial in which no information was withheld from the participating investigators. A pre- and post-treatment controlled study approach was used, whereby the investigator injected 35kDa hyaluronan fragment HA35 into the periodontal pocket in a single dose of 100 mg. The distribution of injection amount was determined by the location of gingival inflammation. The clinical effects of gingival discomfort or itching, redness and swelling, and bleeding from the probing were observed and recorded in patients before and after 7 days of treatment.
Interventions
The clinical effects of gingival discomfort oritching, redness and swelling, and bleeding from the probing were observed and recorded in patients before and after 7 days of treatment.
Sponsors
Dove Medical Press Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
an open-label, single-arm clinical study comparing pre- and post-treatment effects
Intervention model description
an open-label, single-arm clinical study comparing pre- and post-treatment effects
Eligibility
Sex/Gender
ALL
Age
32 Years to 62 Years
Healthy volunteers
No
Inclusion criteria
1. Mild periodontitis and associated with gingival discomfort or itchiness. 2. Patient \> 18 years old. 3. Systemically healthy individuals
Exclusion criteria
1. Patients who take Anticoagulants or Antiplatelet Agents 2. Pregnant or breastfeeding women 3. Patient having expressed his opposition to participate in the research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival discomfort scores | 7 days | This study used a modified pain scale to assess gingival discomfort or itching relief. This quantitative assessment represents the degrees of relief of gingival discomfort. Each patient rated their gingival discomfort or itching on a scale of 0 to 10. 0 means no gingival discomfort or itching and 10 means worst gingival discomfort or itching. Pain intensity levels were assessed before and after 7 days of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The scores of reduction in the extent of gingival redness and swelling and the reduction in gingival bleeding. | 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 gingival redness and swelling; 10 means highest intensity of gingival redness and swelling, which is the state of gingival redness and swelling before treatment. |
| The scores of reduction in gingival bleeding. | 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. 0 indicating no gingival bleeding and 10 indicating most gingival bleeding from the probe, which is the pre-treatment state. |
Countries
China
Outcome results
None listed