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Objective: The aim of this study is to evaluate the effect of HA as an adjunct to scaling and root planning (SRP) on clinical parameters, periodontal inflamed surface area (PISA) and adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival crevicular fluid (GCF) in patients with periodontitis.
Design: A total of 24 Stage II-III periodontitis patients will be included in this split-mouth, randomized-controlled study. The study population will be divided into four groups: in Group 1 (SRP): SRP+ saline; in Group 2 (SRP+HAgel): SRP + HA gel; in Group 3 (SRP+HAmo): SRP+ HA mouthrinse; and in Group 4 (SRP+HAmo+HAgel): SRP+HA mouthrinse + HA gingival gel were applied. At baseline and Week 4 periodontal clinical parameters and PISA will be calculated. Also, GCF amount will be collected to evaluate ADA, CAT, and GSH by spectrophotometric analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaling and root planning (SRP) | Placebo Comparator | Under local anesthesia, full-mouth SRP was performed within 24 h in a single or two sessions using ultrasonic and hand instruments (Gracey, Hu-Friedy, Chicago, IL, USA) by a single investigator (DA). Immediately after the SRP, HA gel (Gengigel, Hyaluronic acid, gingival gel, Ricefarma S.R.L, Italy) or mouthrinse was performed according to the groups' procedure. In Group 1, the periodontal sulcus was irrigated with saline solution after SRP. |
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| Hyaluronic acid gel (HA) and SRP | Experimental | Group 2, after SRP was performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA was applied intrasulcular. |
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| HA mouthrinse and SRP | Experimental | In Group 3, HA hydrogel mouthrinse (Gengigel, Hyaluronic acid, Hydrogel moutrinse for gums, Ricefarma S.R.L, Italy) were used as an irrigator after SRP. |
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| HA mouthrinse+gel and SRP | Experimental | In Group 4, after SRP was performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel was applied. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and root planning | Procedure | Under local anesthesia, full-mouth SRP will be performed by a single investigator. Immediately after the SRP, HA gel or mouthrinse will perform according to the groups' procedure. In Group 1, the periodontal sulcus will be irrigated with saline solution after SRP. |
| Measure | Description | Time Frame |
|---|---|---|
| plaque index | in accordance with the Sillness and Löe index (Silness & Löe, 1964) | Change from Baseline to week 4 |
| gingival index (GI) | confirming to Silness and Löe index (Löe & Silness, 1963) | Change from Baseline to week 4 |
| bleeding on probing (BOP) | according to Ainoma and Bay (AINAMO & Bay, 1975); | Change from Baseline to week 4 |
| Probing depth (PD) | as the measurement of the length between the bottom of the periodontal pocket to marginal gingiva; | Change from Baseline to week 4 |
| gingival recession height (GRH) | as the measurement of the distance between the marginal gingiva and cemento-enamel junction | Change from Baseline to week 4 |
| clinical attachment level (CAL) | as the sum of gingival recession height and probing depth will be recorded. | Change from Baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Periodontal inflammed surface area | All clinical parameters will be entered on Microsoft Excel Program (www.parsprototo.info) which constructed for calculating PISA. The BOP percentage for each tooth will be calculated by entering "number sites with BOP" values in the Excel program. | Change from Baseline Baseline to week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hacer Sahin Aydinyurt, Assist Prof | Yuzuncu Yil University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yuzuncu Yil University Faculty of Dentistry | Van | 65080 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32436173 | Derived | Aydinyurt HS, Akbal D, Altindal D, Bozoglan A, Ertugrul AS, Demir H. Evaluation of biochemical and clinical effects of hyaluronic acid on non-surgical periodontal treatment: a randomized controlled trial. Ir J Med Sci. 2020 Nov;189(4):1485-1494. doi: 10.1007/s11845-020-02230-6. Epub 2020 May 21. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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| Hyaluronic acid gel (HA) and SRP | Drug | In Group 2, after SRP will be performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA will be applied intrasulcular. |
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| HA mouthrinse and SRP | Drug | In Group 3, HA hydrogel mouthrinse will be used as an irrigator after SRP. |
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| HA mouthrinse+gel and SRP | Drug | In Group 4, after SRP will be performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel will be applied. |
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| Changes of Adenosine deaminase (ADA) levels in gingival crevicular fluid |
The ADA activity will be evaluated spectrophotometrically |
| Changes from Baseline to week 1,2,4 |
| Changes of Catalase levels in gingival crevicular fluid | The catalase activity will be evaluated spectrophotometrically | Changes from Baseline to week 1,2,4 |
| Changes of Glutathione levels in gingival crevicular fluid | The Glutathione activity will be evaluated spectrophotometrically | Changes from Baseline to week 1,2,4 |