Peridontal DiseaseNCT07473453
Hyalouronic Acid and Periodontal Surgery
A study testing Hyalouronic Acid in people with Peridontal Disease, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
This study investigated the effectiveness of hyaluronic acid gel in enhancing soft tissue healing after periodontal surgery for residual pockets (5-8 mm). A 3-month prospective, randomized controlled trial included 26 patients from Aristotle University's Postgraduate Periodontology Clinic who had completed initial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peridontal Disease
- What is being tested?
- Hyalouronic Acid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteGreece
- Study dates
- 16 Apr 2024to 19 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of at least one residual pocket with depth 5-8mm at the follow - up examination, after the completion of Steps 1 and 2 of the initial etiological periodontal therapy.
Who cannot join
- severe systematic disease of patients by which a surgical procedure cannot be performed (e.g., uncontrolled diabetes, chemotherapy, immunosuppressive therapy, use of bisphosphonates)
- previous periodontal surgery at the site of the lesion
- antibiotic intake in the last one month before treatment
- patients who smoke more than 10 cigarettes per days
- use drugs or alcohol
- women in pregnancy or lactation period
- periodontal lesions indicated for regeneration (3-walled, craters) were excluded from the study and were threated accordingly
Trial locations and contacts
1 site in 1 country.
Greece1 site
Aristotle University of Thessaloniki, School of Dentistry
Thessaloniki, Central Macedonia, 54124
About this study
Official title: Healing Effect of Hyaluronic Acid Gel in Conjunction With Periodontal Surgery. A Randomized Controlled Clinical and Biomarkers Study
This study investigated the effectiveness of hyaluronic acid gel in enhancing soft tissue healing after periodontal surgery for residual pockets (5-8 mm). A 3-month prospective, randomized controlled trial included 26 patients from Aristotle University's Postgraduate Periodontology Clinic who had completed initial periodontal therapy and exhibited at least one residual pocket.
Participants were randomly assigned to an experimental group (receiving 0.6 ml hyaDENT BG hyaluronic acid gel) or a control group (receiving 0.6 ml saline). Before surgery, gingival crevicular fluid (GCF) samples were collected for inflammatory and healing biomarkers (PGE-2, MMP-9, IL-1β, VEGF, EGF), analyzed using ELISA. Surgery was performed at sites with persistent pockets, and follow-ups occurred at 14 days and 3 months postoperatively.
Healing was assessed using the Landry, Turnbull, and Howley Wound Healing Index (WHI). Clinical parameters, including probing pocket depth (PPD), bleeding on probing (BoP), clinical attachment level (CAL), and plaque index (PI), were measured at 3 months, with treatment success defined as PPD ≤4 mm without BoP. Patient-reported outcomes, such as pain, swelling, chewing, speech, and aesthetics, were evaluated using a Visual Analog Scale (VAS).
Read the detailed description
The current study aimed to investigate the effectiveness of hyaluronic acid gel in accelerating soft tissue healing following periodontal surgery for the treatment of residual periodontal pockets with a depth of 5-8 millimeters.
A prospective, randomized controlled clinical study with a duration of 3 months was designed. Twenty six (26) patients attending the Postgraduate Periodontology Clinic of the Dental School at Aristotle University of Thessaloniki (AUTH). These patients had completed Steps 1 and 2 of initial causative periodontal therapy and had at least one residual periodontal pocket with a depth of 5-8 mm during the re-evaluation (according to the 2018 classification of periodontal and peri-implant diseases). Clinical measurements and radiographic evaluation were performed using the parallel technique, and patients received oral hygiene instructions as part of the initial assessment. Surgical intervention was scheduled two weeks later at sites showing a periodontal pocket depth of 5-8 mm during re-evaluation. The participants were randomly assigned to one of two groups: the experimental group, which received surgical treatment with 0.6 ml of hyaDENT BG hyaluronic acid gel inside the flap, and the control group, which received surgical treatment with 0.6 ml of normal saline (placebo). Prior to surgery, two sterile paper strips (Periostrips) were used to collect gingival crevicular fluid (GCF) samples for inflammatory biomarkers (PGE-2, MMPs-9, IL-1β) and markers for angiogenesis and epithelial cell proliferation (VEGF, EGF). Biomarker concentrations were assessed using the Elisa technique. The patients were followed up on the 14th day and at 3 months post-surgery. GCF samples were taken from the same periodontal pocket on the 14th day (after suture removal) for the evaluation of VEGF and EGF, and at 3 months for the study of PGE-2, MMP-9, and IL-1β. Clinical re-assessments were conducted at 3 months, including measurements of pocket depth (PPD), bleeding on probing (BoP), clinical attachment level (CAL), and plaque index (PI). Treatment success was defined as a pocket depth of ≤4 mm without bleeding on probing at the initial lesion sites. Soft tissue healing was evaluated macroscopic using the Landry, Turnbull, and Howley Wound Healing Index (WHI). Postoperative pain, swelling, chewing and speaking ability, and appearance were assessed using a Visual Analog Scale (VAS).
- Conditions
- Peridontal Disease
- Being tested
- Hyalouronic Acid, Saline solution / placebo
- Keywords
- periodontal surgery, hyalouronic acid, healing, biomarkers, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyalouronic AcidProcedure or surgery
Periodontal surgery and Hyalouronic acid
Saline solution / placeboProcedure or surgery
Periodontal surgery and saline solution/ placebo
| Study group | Role | What they receive |
|---|---|---|
| Periodontal surgery and Hyalouronic acid | Experimental | Test Group (Group HA): periodontal surgery and application of 0.6 ml of hyaDENT BG hyaluronic acid gel Receives: Procedure: Hyalouronic Acid |
| Periodontal surgery and saline solution/ placebo | Placebo comparator | Control group (Group C):periodontal surgery and application of 0.6 ml of saline solution/placebo. Receives: Procedure: Saline solution / placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket depth - change in millimeters (mm)
Periodontal pockrt depth is measured using a periodontal probe at six sites per tooth. (Periodontal probe UNC15, Hu-Friedy, Rotterdam, the Netherlands)
Measured: Baseline to 3 months
Secondary outcomes (7)
Clinical Attachment Level-CAL in millimeters (mm).
Clinical Periodontal Marker: The distance in mm from the CEJ to the gingival margin (Periodontal probe UNC15, Hu-Friedy, Rotterdam, the Netherlands) Time Frame: 6 months
Measured: Baseline to 3 months
Bleeding on Probing-BoP - Change in percentage
Clinical Periodontal Marker: Bleeding after slight pressure by a standardized (dimensions and shape) periodontal probe with a controlled (∼0.25 N) force to the apical end of the sulcus (Periodontal probe UNC15, Hu-Friedy, Rotterdam, the Netherlands)
Measured: baseline to 3 months
Plaque Index-PI - Change in percentage
PI : Assessment of plaque accumulation at six sites per tooth. Percentage of sites with plaque on probing.
Measured: baseline to 3 months
Interleukin-1 beta-IL-1β in pg/ml
IL-1β: Gingival crevicular fluid levels of Interleukin-1 beta (IL-1β) using perio strips into the gingival sulcus.
Unit of Measure: pg/mL
Measured: baseline to 3 months
Vascular Endothelial Growth Factor-VEGF in pg/ml
VEGF: Gingival crevicular fluid levels of Vascular Endothelial Growth Factor using perio strips into the gingival sulcus.
Unit of Measure: pg/mL
Measured: 14 days post-treatment
Early Wound Healing Index by Landry, Turnbull, and Howley in score range 0-5
Early Wound Healing Index Score:
Soft tissue healing assessed using the Early Wound Healing Index by Landry, Turnbull, and Howley. Scores range from 0 to 5. Higher scores indicate better healing.
Unit of Measure: Score (0 worst-5 better )
Measured: 14 days post-treatment
Patient-Reported treatment Experience in VAS score
Patient-Reported treatment Experience Overall treatment experience assessed using a Visual Analog Scale (VAS). Scores range from 1 to 10. Higher scores indicate better patient-reported experience. Unit of Measure:1(worst)-10(better)
Measured: 14 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start16 Apr 2024
- Primary completion19 Feb 2025
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peridontal DiseaseStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elpiniki Vlachodimou, MSc, Principal investigator, Aristotle University Of ThessalonikiAikaterini - Elisavet Doufexi, Assistant Professor, Study director, Aristotle University Of ThessalonikiIoannis Vouros, Professor, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473453
- Sponsor's protocol ID
- 22/27.03.2024
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Effect of Hyaluronic Acid Gel in Conjunction With Periodontal Surgery. A Randomized Controlled Clinical and Biomarkers Study
- ClinicalTrials.gov ID
- NCT07473453
- Acronym / sponsor ID
- 22/27.03.2024
- Conditions
- Peridontal Disease
- Keywords
- periodontal surgery, hyalouronic acid, healing, biomarkers, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 16 Mar 2026 (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.
This study investigated the effectiveness of hyaluronic acid gel in enhancing soft tissue healing after periodontal surgery for residual pockets (5-8 mm). A 3-month prospective, randomized controlled trial included 26 patients from Aristotle University's Postgraduate Periodontology Clinic who had completed initial periodontal therapy and exhibited at least one residual pocket.
Participants were randomly assigned to an experimental group (receiving 0.6 ml hyaDENT BG hyaluronic acid gel) or a control group (receiving 0.6 ml saline). Before surgery, gingival crevicular fluid (GCF) samples were collected for inflammatory and healing biomarkers (PGE-2, MMP-9, IL-1β, VEGF, EGF), analyzed using ELISA. Surgery was performed at sites with persistent pockets, and follow-ups occurred at 14 days and 3 months postoperatively.
Healing was assessed using the Landry, Turnbull, and Howley Wound Healing Index (WHI). Clinical parameters, including probing pocket depth (PPD), bleeding on probing (BoP), clinical attachment level (CAL), and plaque index (PI), were measured at 3 months, with treatment success defined as PPD ≤4 mm without BoP. Patient-reported outcomes, such as pain, swelling, chewing, speech, and aesthetics, were evaluated using a Visual Analog Scale (VAS).
Detailed description
The current study aimed to investigate the effectiveness of hyaluronic acid gel in accelerating soft tissue healing following periodontal surgery for the treatment of residual periodontal pockets with a depth of 5-8 millimeters.
A prospective, randomized controlled clinical study with a duration of 3 months was designed. Twenty six (26) patients attending the Postgraduate Periodontology Clinic of the Dental School at Aristotle University of Thessaloniki (AUTH). These patients had completed Steps 1 and 2 of initial causative periodontal therapy and had at least one residual periodontal pocket with a depth of 5-8 mm during the re-evaluation (according to the 2018 classification of periodontal and peri-implant diseases). Clinical measurements and radiographic evaluation were performed using the parallel technique, and patients received oral hygiene instructions as part of the initial assessment. Surgical intervention was scheduled two weeks later at sites showing a periodontal pocket depth of 5-8 mm during re-evaluation. The participants were randomly assigned to one of two groups: the experimental group, which received surgical treatment with 0.6 ml of hyaDENT BG hyaluronic acid gel inside the flap, and the control group, which received surgical treatment with 0.6 ml of normal saline (placebo). Prior to surgery, two sterile paper strips (Periostrips) were used to collect gingival crevicular fluid (GCF) samples for inflammatory biomarkers (PGE-2, MMPs-9, IL-1β) and markers for angiogenesis and epithelial cell proliferation (VEGF, EGF). Biomarker concentrations were assessed using the Elisa technique. The patients were followed up on the 14th day and at 3 months post-surgery. GCF samples were taken from the same periodontal pocket on the 14th day (after suture removal) for the evaluation of VEGF and EGF, and at 3 months for the study of PGE-2, MMP-9, and IL-1β. Clinical re-assessments were conducted at 3 months, including measurements of pocket depth (PPD), bleeding on probing (BoP), clinical attachment level (CAL), and plaque index (PI). Treatment success was defined as a pocket depth of ≤4 mm without bleeding on probing at the initial lesion sites. Soft tissue healing was evaluated macroscopic using the Landry, Turnbull, and Howley Wound Healing Index (WHI). Postoperative pain, swelling, chewing and speaking ability, and appearance were assessed using a Visual Analog Scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal surgery and Hyalouronic acid | Experimental | Procedure: Hyalouronic AcidTest Group (Group HA): periodontal surgery and application of 0.6 ml of hyaDENT BG hyaluronic acid gel |
| Periodontal surgery and saline solution/ placebo | Placebo comparator | Procedure: Saline solution / placeboControl group (Group C):periodontal surgery and application of 0.6 ml of saline solution/placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the presence of at least one residual pocket with depth 5-8mm at the follow - up examination, after the completion of Steps 1 and 2 of the initial etiological periodontal therapy.
Key exclusion criteria (7 listed)
- severe systematic disease of patients by which a surgical procedure cannot be performed (e.g., uncontrolled diabetes, chemotherapy, immunosuppressive therapy, use of bisphosphonates)
- previous periodontal surgery at the site of the lesion
- antibiotic intake in the last one month before treatment
- patients who smoke more than 10 cigarettes per days
- use drugs or alcohol
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 |
|---|---|---|
| Hyalouronic AcidPeriodontal surgery and Hyalouronic acid | Procedure or surgery | Periodontal surgery and Hyalouronic acid |
| Saline solution / placeboPeriodontal surgery and saline solution/ placebo | Procedure or surgery | Periodontal surgery and saline solution/ placebo |
Primary outcome
Periodontal pocket depth - change in millimeters (mm)
Time frame: Baseline to 3 months
Periodontal pockrt depth is measured using a periodontal probe at six sites per tooth. (Periodontal probe UNC15, Hu-Friedy, Rotterdam, the Netherlands)
7 secondary outcomes
Clinical Attachment Level-CAL in millimeters (mm).
Time frame: Baseline to 3 months
Bleeding on Probing-BoP - Change in percentage
Time frame: baseline to 3 months
Plaque Index-PI - Change in percentage
Time frame: baseline to 3 months
Interleukin-1 beta-IL-1β in pg/ml
Time frame: baseline to 3 months
Vascular Endothelial Growth Factor-VEGF in pg/ml
Time frame: 14 days post-treatment
Early Wound Healing Index by Landry, Turnbull, and Howley in score range 0-5
Time frame: 14 days post-treatment
Patient-Reported treatment Experience in VAS score
Time frame: 14 days post-treatment
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 16 Mar 2026.
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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.
Elpiniki Vlachodimou, MSc principal investigator
Aristotle University Of Thessaloniki
Aikaterini - Elisavet Doufexi, Assistant Professor study director
Aristotle University Of Thessaloniki
Ioannis Vouros, Professor study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyalouronic Acid in people with Peridontal Disease, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 1 inclusion and 7 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 16 Mar 2026. 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 Greece. 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. Some participants in this study may receive a placebo. 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?
Periodontal pocket depth - change in millimeters (mm) (time frame: Baseline to 3 months). 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 16 Mar 2026.