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Completed

NCT Number: NCT06842511

Effects of the Adjunctive Use of Hyaluronic Acid-based Gel in the Surgical Periodontal Treatment of Periodontitis

This study aimed to assess the effect of Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent in surgical periodontal treatment on clinical parameters and cytokine levels (IL-6, IL-8, IL-10, IL-17A, TOS, and TAS) in gingival crevicular fluid (GCF) among periodontitis patients.

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Key information

Conditions

Periodontitis (Stage 3) Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ordu University

Ordu, Altınordu, 52100, Turkey (Türkiye)

About this study

The aim of this study is to evaluate the effects of adjunctive Hyaluronic Acid-Based Gel (HA) application in the surgical treatment of patients with moderate to severe stage III periodontitis (Grade B or C) on clinical parameters, as well as on IL-6, IL-8, IL-10, IL-17, TAS, and TOS levels in gingival crevicular fluid (GCF) to determine its anti-inflammatory and antioxidant efficacy.

This split-mouth study included 18 patients (mean age 43.44±8.12 years) diagnosed with Stage III Grade B or C periodontitis. Quadrants were randomly assigned to two groups: Group 1 (control: open flap debridement [OFD], n=18) and Group 2 (test: OFD + 0.8% HA gel, n=18). Baseline (T0) assessments included plaque index (PI), gingival index (GI), bleeding on probing index (BPI), probing pocket depth (PPD), clinical attachment level (CAL), and GCF collection. Following non-surgical treatment, patients underwent OFD; HA gel was applied to defect sites in the test group and saline in the control. Clinical parameters and GCF sampling were repeated pre-surgery (TS-1), and at 1 month (TS-2) and 6 months (TS-3) post-surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stage III Grade B or C periodotitis
  • over 18 years old
  • signed the informed consent

Exclusion criteria

  • pregnancy, or lactation,
  • systemic problems that would contraindicate for periodontal surgery,
  • prosthetic restorations in the test or control teeth,
  • taking medications that affect wound healing (corticosteroids, anticancer agents, etc),
  • using nonsteroidal anti-inflammatory drugs, using any antibiotics and anti-inflammatory drugs in the last 6 months,
  • alcohol abuse and smoking use

Treatment and study plan

open flap debridement and Hyaluronic Acid-Based Gel application

Drug

Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent

Other names: Test group

Open Flap debridement

Procedure

periodontal surgery technique

Other names: Control group

Primary outcomes

  1. Plaque Index

    Time frame: Baseline

    to assess plaque accumulation

  2. Plaque Index

    Time frame: Pre-surgery

    to assess plaque accumulation

  3. Plaque Index

    Time frame: post-surgery 1 month

    to assess plaque accumulation

  4. Plaque Index

    Time frame: post-surgery 6 months

    to assess plaque accumulation

  5. Gingival Index

    Time frame: Baseline

    for evaluating gingival inflammation

  6. Gingival Index

    Time frame: Pre-surgery

    for evaluating gingival inflammation

  7. Gingival Index

    Time frame: post-surgery 1 month

    for evaluating gingival inflammation

  8. Gingival Index

    Time frame: post-surgery 6 months

    for evaluating gingival inflammation

  9. Probing pocket depth

    Time frame: Baseline

    for measuring disease severity

  10. Probing pocket depth

    Time frame: pre-surgery

    for measuring disease severity

  11. Probing pocket depth

    Time frame: post-surgery 1 months

    for measuring disease severity

  12. Probing pocket depth

    Time frame: post-surgery 6 months

    for measuring disease severity

  13. clinical attachment level

    Time frame: Baseline

    Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.

  14. clinical attachment level

    Time frame: pre-surgery

    Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.

  15. clinical attachment level

    Time frame: post-surgery 1 months

    Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.

  16. clinical attachment level

    Time frame: post-surgery 6 months

    Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.

  17. Bleeding on Probing

    Time frame: baseline

    to assess disease activity

  18. Bleeding on Probing

    Time frame: pre-surgery

    to assess disease activity

  19. Bleeding on Probing

    Time frame: post-surgery 1 months

    to assess disease activity

  20. Bleeding on Probing

    Time frame: post-surgery 6 months

    to assess disease activity

  21. IL-6

    Time frame: Baseline

    IL-6 levels in gingival crevicular fluid (GCF)

  22. IL-8

    Time frame: baseline

    IL-8 levels in gingival crevicular fluid (GCF)

  23. IL-17A

    Time frame: baseline

    IL-17A levels in gingival crevicular fluid (GCF)

  24. IL-10

    Time frame: baseline

    IL-10 levels in gingival crevicular fluid (GCF)

  25. Total antioxidant status

    Time frame: baseline

    TAS levels in gingival crevicular fluid (GCF)

  26. Total oxidant status

    Time frame: baseline

    TOS levels in gingival crevicular fluid (GCF)

  27. IL-6

    Time frame: pre-surgery

    IL-6 levels in gingival crevicular fluid (GCF)

  28. IL-8

    Time frame: pre-surgery

    IL-8 levels in gingival crevicular fluid (GCF)

  29. IL-17A

    Time frame: pre-surgery

    IL-17A levels in gingival crevicular fluid (GCF)

  30. IL-10

    Time frame: pre-surgery

    IL-10 levels in gingival crevicular fluid (GCF)

  31. Total antioxidant status

    Time frame: pre-surgery

    TAS levels in gingival crevicular fluid (GCF)

  32. Total oxidant status

    Time frame: pre-surgery

    TOS levels in gingival crevicular fluid (GCF)

  33. IL-6

    Time frame: post-surgery 1 month

    IL-6 levels in gingival crevicular fluid (GCF)

  34. IL-8

    Time frame: post-surgery 1 month

    IL-8 levels in gingival crevicular fluid (GCF)

  35. IL-17A

    Time frame: post-surgery 1 month

    IL-17A levels in gingival crevicular fluid (GCF)

  36. IL-10

    Time frame: post-surgery 1 month

    IL-10 levels in gingival crevicular fluid (GCF)

  37. Total antioxidant status

    Time frame: post-surgery 1 month

    TAS levels in gingival crevicular fluid (GCF)

  38. Total oxidant status

    Time frame: post-surgery 1 month

    TOS levels in gingival crevicular fluid (GCF)

  39. IL-6

    Time frame: post-surgery 6 month

    IL-6 levels in gingival crevicular fluid (GCF)

  40. IL-8

    Time frame: post-surgery 6 month

    IL-8 levels in gingival crevicular fluid (GCF)

  41. IL-17A

    Time frame: post-surgery 6 month

    IL-17A levels in gingival crevicular fluid (GCF)

  42. IL-10

    Time frame: post-surgery 6 month

    IL-10 levels in gingival crevicular fluid (GCF)

  43. Total antioxidant status

    Time frame: post-surgery 6 month

    TAS levels in gingival crevicular fluid (GCF)

  44. Total oxidant status

    Time frame: post-surgery 6 month

    TOS levels in gingival crevicular fluid (GCF)

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

Effects on the Anti-inflammatory and Antioxidant Levels of the Adjunctive Use of Hyaluronic Acid-based Gel in the Surgical Periodontal Treatment of Stage III Periodontitis Patients: A Randomized, Split-mouth Clinical Trial

Acronym: Periodontit

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

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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