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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontal surgery and Hyalouronic acid | Experimental | Test 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 | Control group (Group C):periodontal surgery and application of 0.6 ml of saline solution/placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyalouronic Acid | Procedure | Periodontal surgery and Hyalouronic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 3 months |
| Bleeding on Probing-BoP - Change in percentage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elpiniki Vlachodimou, MSc | Aristotle University Of Thessaloniki | Principal Investigator |
| Aikaterini - Elisavet Doufexi, Assistant Professor | Aristotle University Of Thessaloniki | Study Director |
| Ioannis Vouros, Professor | Aristotle University Of Thessaloniki | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aristotle University of Thessaloniki, School of Dentistry | Thessaloniki | Central Macedonia | 54124 | Greece |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: corrections | Mar 21, 2023 | Mar 3, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Saline solution / placebo | Procedure | Periodontal surgery and saline solution/ placebo |
|
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) |
| 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. | 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 | 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 | 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 ) | 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) | 14 days post-treatment |