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NCT Number: NCT05812300

Local Injection of Periodontal Pocket Method for the Treatment of 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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huinuode Biotechnology Co., Ltd.

Qingdao, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Freshly manufactured 35 kDa hyaluronan fragment

Drug

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.

Other names: HA35

Primary outcomes

  1. 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".

  2. 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".

  3. 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"

Sponsors and collaborators

Lead sponsor

Dove Medical Press Ltd

Network

Registry information

Official study title

The Clinical Study of Injection of Freshly Prepared HA35 for Treatment Gingivitis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2023
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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