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Periodontitis (Stage 3)Phase 1/2PeriodontitNCT06842511

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

A Phase 1/2 study testing open flap debridement and Hyaluronic Acid-Based Gel application and open flap debridement in people with Periodontitis (Stage 3), run by Ordu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 25 to 55 years
Conditions the study is for
Periodontitis (Stage 3)
What is being tested?
open flap debridement and Hyaluronic Acid-Based Gel application and open flap debridement
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Apr 2023to 30 May 2024
Phase
Phase 1/2
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 25 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ordu University

    Ordu, Altınordu, 52100

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read the detailed description

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.

Being tested
open flap debridement and Hyaluronic Acid-Based Gel application, open flap debridement
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • open flap debridement and Hyaluronic Acid-Based Gel applicationDrug

    Also called Test group

    Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent

  • open flap debridementProcedure or surgery

    Also called Control group

    periodontal surgery technique

Study groups in NCT06842511
Study groupRoleWhat they receive
Control groupPlacebo comparatoronly open flap debridement
Receives: Procedure: open flap debridement
Test groupActive comparatoropen flap debridement + adjunctive use of 0.8% hyaluronic acid-based gel
Receives: Drug: open flap debridement and Hyaluronic Acid-Based Gel application; Procedure: open flap debridement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plaque Index

    to assess plaque accumulation

    Measured: Baseline

  2. Plaque Index

    to assess plaque accumulation

    Measured: Pre-surgery

  3. Plaque Index

    to assess plaque accumulation

    Measured: post-surgery 1 month

  4. Plaque Index

    to assess plaque accumulation

    Measured: post-surgery 6 months

  5. Gingival Index

    for evaluating gingival inflammation

    Measured: Baseline

  6. Gingival Index

    for evaluating gingival inflammation

    Measured: Pre-surgery

  7. Gingival Index

    for evaluating gingival inflammation

    Measured: post-surgery 1 month

  8. Gingival Index

    for evaluating gingival inflammation

    Measured: post-surgery 6 months

  9. Probing pocket depth

    for measuring disease severity

    Measured: Baseline

  10. Probing pocket depth

    for measuring disease severity

    Measured: pre-surgery

  11. Probing pocket depth

    for measuring disease severity

    Measured: post-surgery 1 months

  12. Probing pocket depth

    for measuring disease severity

    Measured: post-surgery 6 months

  13. clinical attachment level

    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.

    Measured: Baseline

  14. clinical attachment level

    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.

    Measured: pre-surgery

  15. clinical attachment level

    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.

    Measured: post-surgery 1 months

  16. clinical attachment level

    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.

    Measured: post-surgery 6 months

  17. Bleeding on Probing

    to assess disease activity

    Measured: baseline

  18. Bleeding on Probing

    to assess disease activity

    Measured: pre-surgery

  19. Bleeding on Probing

    to assess disease activity

    Measured: post-surgery 1 months

  20. Bleeding on Probing

    to assess disease activity

    Measured: post-surgery 6 months

  21. IL-6

    IL-6 levels in gingival crevicular fluid (GCF)

    Measured: Baseline

  22. IL-8

    IL-8 levels in gingival crevicular fluid (GCF)

    Measured: baseline

  23. IL-17A

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

    Measured: baseline

  24. IL-10

    IL-10 levels in gingival crevicular fluid (GCF)

    Measured: baseline

  25. Total antioxidant status

    TAS levels in gingival crevicular fluid (GCF)

    Measured: baseline

  26. Total oxidant status

    TOS levels in gingival crevicular fluid (GCF)

    Measured: baseline

  27. IL-6

    IL-6 levels in gingival crevicular fluid (GCF)

    Measured: pre-surgery

  28. IL-8

    IL-8 levels in gingival crevicular fluid (GCF)

    Measured: pre-surgery

  29. IL-17A

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

    Measured: pre-surgery

  30. IL-10

    IL-10 levels in gingival crevicular fluid (GCF)

    Measured: pre-surgery

  31. Total antioxidant status

    TAS levels in gingival crevicular fluid (GCF)

    Measured: pre-surgery

  32. Total oxidant status

    TOS levels in gingival crevicular fluid (GCF)

    Measured: pre-surgery

  33. IL-6

    IL-6 levels in gingival crevicular fluid (GCF)

    Measured: post-surgery 1 month

  34. IL-8

    IL-8 levels in gingival crevicular fluid (GCF)

    Measured: post-surgery 1 month

  35. IL-17A

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

    Measured: post-surgery 1 month

  36. IL-10

    IL-10 levels in gingival crevicular fluid (GCF)

    Measured: post-surgery 1 month

  37. Total antioxidant status

    TAS levels in gingival crevicular fluid (GCF)

    Measured: post-surgery 1 month

  38. Total oxidant status

    TOS levels in gingival crevicular fluid (GCF)

    Measured: post-surgery 1 month

  39. IL-6

    IL-6 levels in gingival crevicular fluid (GCF)

    Measured: post-surgery 6 month

  40. IL-8

    IL-8 levels in gingival crevicular fluid (GCF)

    Measured: post-surgery 6 month

  41. IL-17A

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

    Measured: post-surgery 6 month

  42. IL-10

    IL-10 levels in gingival crevicular fluid (GCF)

    Measured: post-surgery 6 month

  43. Total antioxidant status

    TAS levels in gingival crevicular fluid (GCF)

    Measured: post-surgery 6 month

  44. Total oxidant status

    TOS levels in gingival crevicular fluid (GCF)

    Measured: post-surgery 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start4 Apr 2023
  3. Primary completion30 May 2024
  4. Study completion30 May 2024

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06842511
Sponsor's protocol ID
77158231
Acronym
Periodontit
Status last verified
Feb 2025
First submitted
6 Feb 2025
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing open flap debridement and Hyaluronic Acid-Based Gel application and open flap debridement in people with Periodontitis (Stage 3), run by Ordu University at 1 site in Turkey (Türkiye).

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 3 inclusion and 6 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 24 Feb 2025. 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 Turkey (Türkiye). 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Plaque Index (time frame: Baseline). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06842511.

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 24 Feb 2025.

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