Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis

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.

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.

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.