Does Hyaluronic Acid Affect Periodontal Treatment?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Clinical and Biochemical Effects of Hyaluronic Acid on Periodontitis: A Split-mouth Randomized-controlled Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: Scaling and root planning
* Drug: Hyaluronic acid gel (HA) and SRP
* Drug: HA mouthrinse and SRP
* Drug: HA mouthrinse+gel and SRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy moderate-to-severe periodontitis at least five sites with ≥5mm probing depth (PD) at least ≥20 teeth Stage II-III periodontitis according to the 2017 World Workshop Age between18-55 Exclusion Criteria: receiving systemic or local antibiotics within the past six months prior surgical or non-surgical periodontal treatment within the past six months smoking pregnancy lactation age ≤18 years or ≥55 years hypertension known chronic systemic diseases (i.e., diabetes mellitus, rheumatoid arthritis), - - known hypersensitivity to one of the ingredients of the HA preparation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Scaling and root planning (SRP)<br>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. | Procedure: Scaling and root planning<br>* 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.<br>|
| Experimental: Hyaluronic acid gel (HA) and SRP<br>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. | Procedure: Scaling and root planning<br>* 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.<br>Drug: Hyaluronic acid gel (HA) and SRP<br>* 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.<br>* Other names: HA and SRP;|
| Experimental: HA mouthrinse and SRP<br>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. | Procedure: Scaling and root planning<br>* 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.<br>Drug: HA mouthrinse and SRP<br>* In Group 3, HA hydrogel mouthrinse will be used as an irrigator after SRP.<br>* Other names: HAmo+SRP;|
| Experimental: HA mouthrinse+gel and SRP<br>In Group 4, after SRP was performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel was applied. | Procedure: Scaling and root planning<br>* 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.<br>Drug: HA mouthrinse+gel and SRP<br>* 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.<br>* Other names: HAmo+HAgel+SRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, hyaluronic acid, scaling and root planning, adenosione deaminase, catalase, glutathione