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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | only open flap debridement |
|
| Test group | Active Comparator | open flap debridement + adjunctive use of 0.8% hyaluronic acid-based gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open flap debridement and Hyaluronic Acid-Based Gel application | Drug | Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ordu University | Ordu University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordu University | Ordu | Altınordu | 52100 | Turkey (Türkiye) |
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| open flap debridement | Procedure | periodontal surgery technique |
|
|
| 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 |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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