Does Hyaluronic Acid Affect Periodontal Treatment?

Yuzuncu Yıl University

Status and phase: Completed; Phase 1

Conditions: Periodontitis

Treatments: Drug: Hyaluronic acid gel (HA) and SRP; Drug: HA mouthrinse+gel and SRP; Procedure: Scaling and root planning; Drug: HA mouthrinse and SRP

Study type: Interventional

Funder types: Other

Identifiers

NCT03754010

19.07.2017/09

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

Scaling and root planning (SRP)

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Scaling and root planning

Hyaluronic acid gel (HA) and SRP

Experimental group

Description:

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.

Treatment:

Procedure: Scaling and root planning

Drug: Hyaluronic acid gel (HA) and SRP

HA mouthrinse and SRP

Experimental group

Description:

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.

Treatment:

Drug: HA mouthrinse and SRP

Procedure: Scaling and root planning

HA mouthrinse+gel and SRP

Experimental group

Description:

In Group 4, after SRP was performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel was applied.

Treatment:

Procedure: Scaling and root planning

Drug: HA mouthrinse+gel and SRP