Evaluation of Clinical and Biochemical Effects of Hyaluronic Acid on Periodontitis: A Split-mouth Randomized-controlled Trial
| Registry | NCT03754010 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: triple, treatment |
| Enrollment | 24 (Actual) |
| Sponsor | Yuzuncu Yil University (Other) |
| Conditions | Periodontitis |
| Interventions | Scaling and root planning, Hyaluronic acid gel (HA) and SRP, HA mouthrinse and SRP, HA mouthrinse+gel and SRP (Procedure, drug) |
| Dates | start 2017-08-30, primary completion 2018-04-30, completion 2018-09-30, first posted 2018-11-27, last updated 2018-11-27 |
| Locations | 1 site in Turkey (Türkiye) |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Scaling and root planning (SRP) | Placebo comparator | Procedure: Scaling and root planning | 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. |
| Hyaluronic acid gel (HA) and SRP | Experimental | Procedure: Scaling and root planning; Drug: Hyaluronic acid gel (HA) and SRP | 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. |
| HA mouthrinse and SRP | Experimental | Procedure: Scaling and root planning; Drug: HA mouthrinse and SRP | 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. |
| HA mouthrinse+gel and SRP | Experimental | Procedure: Scaling and root planning; Drug: HA mouthrinse+gel and SRP | In Group 4, after SRP was performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel was applied. |
Sex: All, ages: 18 Years to 55 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Van Yuzuncu Yil University Faculty of Dentistry | Van | Turkey (Türkiye) |