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Completed

NCT Number: NCT07473453

Hyalouronic Acid and Periodontal Surgery

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aristotle University of Thessaloniki, School of Dentistry

Thessaloniki, Central Macedonia, 54124, Greece

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Hyalouronic Acid

Procedure

Periodontal surgery and Hyalouronic acid

Saline solution / placebo

Procedure

Periodontal surgery and saline solution/ placebo

Primary outcomes

  1. 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)

Secondary outcomes

  1. Clinical Attachment Level-CAL in millimeters (mm).

    Time frame: Baseline to 3 months

    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

  2. Bleeding on Probing-BoP - Change in percentage

    Time frame: baseline to 3 months

    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)

  3. Plaque Index-PI - Change in percentage

    Time frame: baseline to 3 months

    PI : Assessment of plaque accumulation at six sites per tooth. Percentage of sites with plaque on probing.

  4. Interleukin-1 beta-IL-1β in pg/ml

    Time frame: baseline to 3 months

    IL-1β: Gingival crevicular fluid levels of Interleukin-1 beta (IL-1β) using perio strips into the gingival sulcus.

    Unit of Measure: pg/mL

  5. Vascular Endothelial Growth Factor-VEGF in pg/ml

    Time frame: 14 days post-treatment

    VEGF: Gingival crevicular fluid levels of Vascular Endothelial Growth Factor using perio strips into the gingival sulcus.

    Unit of Measure: pg/mL

  6. Early Wound Healing Index by Landry, Turnbull, and Howley in score range 0-5

    Time frame: 14 days post-treatment

    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 )

  7. Patient-Reported treatment Experience in VAS score

    Time frame: 14 days post-treatment

    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)

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Healing Effect of Hyaluronic Acid Gel in Conjunction With Periodontal Surgery. A Randomized Controlled Clinical and Biomarkers Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

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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