PeriodontitisNCT05765513
HA35 Treatment the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis
A study testing HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089) in people with Periodontitis, run by Dove Medical Press Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 62 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)
- 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
- 2 Feb 2023to 11 Aug 2023
- 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 32 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild periodontitis and associated with gingival discomfort or itchiness.
- Patient > 18 years old.
- Systemically healthy individuals
Who cannot join
- Patients who take Anticoagulants or Antiplatelet Agents
- Pregnant or breastfeeding women
- Patient having expressed his opposition to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-pocket Injection of a Freshly Manufactured 35 kDa Hyaluronan Fragment HA35 Reduces the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis: A Clinical Study
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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)
- Keywords
- 35 kDa low molecular hyaluronan fragment, HA35, Tissue permeability, Intra-pocket injection, Gingival redness and bleeding
- Medical subject headings
- Periodontitis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)Drug
Also called HA35
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.
| Study group | Role | What they receive |
|---|---|---|
| 35kDa hyaluronan fragment HA35 injection | Experimental | 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. Receives: Drug: HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival discomfort scores
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.
Measured: 7 days
Secondary outcomes (2)
The scores of reduction in the extent of gingival redness and swelling and the reduction in gingival bleeding.
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.
Measured: 7 days
The scores of reduction in gingival bleeding.
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.
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 Mar 2023
- Study start2 Feb 2023
- Primary completion20 Jul 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- an open-label, single-arm clinical study comparing pre- and post-treatment effects
- 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
- NCT05765513
- Sponsor's protocol ID
- hui20050910
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
APPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286
Jia X, Shi M, Wang Q, Hui J, Shofaro JH, Erkhembayar R, Hui M, Gao C, Gantumur MA. Anti-Inflammatory Effects of the 35kDa Hyaluronic Acid Fragment (B-HA/HA35). J Inflamm Res. 2023 Jan 13;16:209-224. doi: 10.2147/JIR.S393495. eCollection 2023.
PubMed 36686276
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-pocket Injection of a Freshly Manufactured 35 kDa Hyaluronan Fragment HA35 Reduces the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis: A Clinical Study
- ClinicalTrials.gov ID
- NCT05765513
- Acronym / sponsor ID
- hui20050910
- Conditions
- Periodontitis
- Keywords
- 35 kDa low molecular hyaluronan fragment, HA35, Tissue permeability, Intra-pocket injection, Gingival redness and bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dove Medical Press LtdResearch network
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 13 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- an open-label, single-arm clinical study comparing pre- and post-treatment effects
| Arm | Type | Receives |
|---|---|---|
| 35kDa hyaluronan fragment HA35 injection | Experimental | Drug: HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)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. |
Who may qualify
- Ages
- 32 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mild periodontitis and associated with gingival discomfort or itchiness.
- Patient > 18 years old.
- Systemically healthy individuals
Key exclusion criteria (3 listed)
- Patients who take Anticoagulants or Antiplatelet Agents
- Pregnant or breastfeeding women
- Patient having expressed his opposition to participate in the research.
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 |
|---|---|---|
| HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)Also: HA35The 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. | Drug | 35kDa hyaluronan fragment HA35 injection |
Primary outcome
Gingival discomfort scores
Time frame: 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.
2 secondary outcomes
The scores of reduction in the extent of gingival redness and swelling and the reduction in gingival bleeding.
Time frame: 7 days
The scores of reduction in gingival bleeding.
Time frame: 7 days
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 31 Oct 2023.
- BackgroundAPPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286
- Results publication: PubMed 36686276Jia X, Shi M, Wang Q, Hui J, Shofaro JH, Erkhembayar R, Hui M, Gao C, Gantumur MA. Anti-Inflammatory Effects of the 35kDa Hyaluronic Acid Fragment (B-HA/HA35). J Inflamm Res. 2023 Jan 13;16:209-224. doi: 10.2147/JIR.S393495. eCollection 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089) 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 3 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 31 Oct 2023. 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?
Gingival discomfort scores (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05765513, which also lists 2 linked publications.
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 31 Oct 2023.