NCT06842511

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

February 6, 2025

Last Update Submit

February 21, 2025

Conditions

Periodontitis (Stage 3)

Outcome Measures

Primary Outcomes (44)

  • Plaque Index

    to assess plaque accumulation

    Baseline

  • Plaque Index

    to assess plaque accumulation

    Pre-surgery

  • Plaque Index

    to assess plaque accumulation

    post-surgery 1 month

  • Plaque Index

    to assess plaque accumulation

    post-surgery 6 months

  • Gingival Index

    for evaluating gingival inflammation

    Baseline

  • Gingival Index

    for evaluating gingival inflammation

    Pre-surgery

  • Gingival Index

    for evaluating gingival inflammation

    post-surgery 1 month

  • Gingival Index

    for evaluating gingival inflammation

    post-surgery 6 months

  • Probing pocket depth

    for measuring disease severity

    Baseline

  • Probing pocket depth

    for measuring disease severity

    pre-surgery

  • Probing pocket depth

    for measuring disease severity

    post-surgery 1 months

  • Probing pocket depth

    for measuring disease severity

    post-surgery 6 months

  • 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.

    Baseline

  • 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.

    pre-surgery

  • 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.

    post-surgery 1 months

  • 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.

    post-surgery 6 months

  • Bleeding on Probing

    to assess disease activity

    baseline

  • Bleeding on Probing

    to assess disease activity

    pre-surgery

  • Bleeding on Probing

    to assess disease activity

    post-surgery 1 months

  • Bleeding on Probing

    to assess disease activity

    post-surgery 6 months

  • IL-6

    IL-6 levels in gingival crevicular fluid (GCF)

    Baseline

  • IL-8

    IL-8 levels in gingival crevicular fluid (GCF)

    baseline

  • IL-17A

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

    baseline

  • IL-10

    IL-10 levels in gingival crevicular fluid (GCF)

    baseline

  • Total antioxidant status

    TAS levels in gingival crevicular fluid (GCF)

    baseline

  • Total oxidant status

    TOS levels in gingival crevicular fluid (GCF)

    baseline

  • IL-6

    IL-6 levels in gingival crevicular fluid (GCF)

    pre-surgery

  • IL-8

    IL-8 levels in gingival crevicular fluid (GCF)

    pre-surgery

  • IL-17A

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

    pre-surgery

  • IL-10

    IL-10 levels in gingival crevicular fluid (GCF)

    pre-surgery

  • Total antioxidant status

    TAS levels in gingival crevicular fluid (GCF)

    pre-surgery

  • Total oxidant status

    TOS levels in gingival crevicular fluid (GCF)

    pre-surgery

  • IL-6

    IL-6 levels in gingival crevicular fluid (GCF)

    post-surgery 1 month

  • IL-8

    IL-8 levels in gingival crevicular fluid (GCF)

    post-surgery 1 month

  • IL-17A

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

    post-surgery 1 month

  • IL-10

    IL-10 levels in gingival crevicular fluid (GCF)

    post-surgery 1 month

  • Total antioxidant status

    TAS levels in gingival crevicular fluid (GCF)

    post-surgery 1 month

  • Total oxidant status

    TOS levels in gingival crevicular fluid (GCF)

    post-surgery 1 month

  • IL-6

    IL-6 levels in gingival crevicular fluid (GCF)

    post-surgery 6 month

  • IL-8

    IL-8 levels in gingival crevicular fluid (GCF)

    post-surgery 6 month

  • IL-17A

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

    post-surgery 6 month

  • IL-10

    IL-10 levels in gingival crevicular fluid (GCF)

    post-surgery 6 month

  • Total antioxidant status

    TAS levels in gingival crevicular fluid (GCF)

    post-surgery 6 month

  • Total oxidant status

    TOS levels in gingival crevicular fluid (GCF)

    post-surgery 6 month

Study Arms (2)

Control group

PLACEBO COMPARATOR

only open flap debridement

Procedure: open flap debridement

Test group

ACTIVE COMPARATOR

open flap debridement + adjunctive use of 0.8% hyaluronic acid-based gel

Drug: open flap debridement and Hyaluronic Acid-Based Gel applicationProcedure: open flap debridement

Interventions

open flap debridement and Hyaluronic Acid-Based Gel applicationDRUG

Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent

Also known as: Test group
Test group
open flap debridementPROCEDURE

periodontal surgery technique

Also known as: Control group
Control groupTest group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, Altınordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ordu University

    Ordu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 24, 2025

Study Start

April 4, 2023

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)