NCT07473453

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

January 30, 2026

Last Update Submit

March 13, 2026

Conditions

Peridontal Disease

Keywords

periodontal surgeryhyalouronic acidhealingbiomarkersRCT

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

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

    Baseline to 3 months

  • Bleeding on Probing-BoP - Change in percentage

    baseline to 3 months

  • Plaque Index-PI - Change in percentage

    baseline to 3 months

  • Interleukin-1 beta-IL-1β in pg/ml

    baseline to 3 months

  • Vascular Endothelial Growth Factor-VEGF in pg/ml

    14 days post-treatment

  • +2 more secondary outcomes

Study Arms (2)

Periodontal surgery and Hyalouronic acid

EXPERIMENTAL

Test Group (Group HA): periodontal surgery and application of 0.6 ml of hyaDENT BG hyaluronic acid gel

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.

Procedure: Saline solution / placebo

Interventions

Hyalouronic AcidPROCEDURE

Periodontal surgery and Hyalouronic acid

Periodontal surgery and Hyalouronic acid
Saline solution / placeboPROCEDURE

Periodontal surgery and saline solution/ placebo

Periodontal surgery and saline solution/ placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aristotle University of Thessaloniki, School of Dentistry

Thessaloniki, Central Macedonia, 54124, Greece

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

March 16, 2026

Study Start

April 16, 2024

Primary Completion

February 19, 2025

Study Completion

May 19, 2025

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

GR(1)