PeriodontitisNCT05812300
Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis
A study testing Freshly manufactured 35 kDa hyaluronan fragment in people with Periodontitis, run by Dove Medical Press Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Freshly manufactured 35 kDa hyaluronan fragment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Freshly manufactured 35 kDa hyaluronan fragment
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freshly manufactured 35 kDa hyaluronan fragmentDrug
Also called HA35
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.
| Study group | Role | What they receive |
|---|---|---|
| HA35 local injection of Periodontal Pocket group | Experimental | 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. Receives: Drug: Freshly manufactured 35 kDa hyaluronan fragment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of gum discomfort
Each patient rated their gingival discomfort or itching on a scale of 0 to 10. 0 means "no", and 10 means "the most".
Measured: 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"; 10 means "highest".
Measured: 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. A score of 0 indicated "no" and 10 indicated "the most"
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Jun 2023
- Primary completion1 Jan 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dove Medical Press Ltd
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812300
- Sponsor's protocol ID
- HSHN003
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be sent to the accepting journal study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Injection of Freshly Prepared HA35 for Treatment Gingivitis
- ClinicalTrials.gov ID
- NCT05812300
- Acronym / sponsor ID
- HSHN003
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dove Medical Press LtdResearch network
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HA35 local injection of Periodontal Pocket group | Experimental | Drug: Freshly manufactured 35 kDa hyaluronan fragmentThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freshly manufactured 35 kDa hyaluronan fragmentAlso: HA35The 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. | Drug | HA35 local injection of Periodontal Pocket group |
Primary outcome
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No. The data will be sent to the accepting journal study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freshly manufactured 35 kDa hyaluronan fragment in people with Periodontitis, run by Dove Medical Press Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of gum discomfort (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.