Does Hyaluronic Acid Affect Periodontal Treatment?

Phase 1

Completed

• Conditions: Periodontitis
• Interventions: Procedure: Scaling and root planning; Drug: Hyaluronic acid gel (HA) and SRP; Drug: HA mouthrinse and SRP; Drug: HA mouthrinse+gel and SRP

• Registration Number: NCT03754010
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-08-30
• Primary Completion: 2018-04-30
• Study Completion: 2018-09-30
• Status Verified: 2018-11
• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-23
• Last Update Submitted: 2018-11-23
• Study First Posted: 2018-11-27
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Scaling and root planning (SRP)	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	Scaling and root planning	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.
Hyaluronic acid gel (HA) and SRP	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	Scaling and root planning	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 and SRP	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	Scaling and root planning	In Group 4, after SRP was performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel was applied.
HA mouthrinse+gel and SRP	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.

Primary Outcome Measures

Name	Time	Method
gingival index (GI)	Change from Baseline to week 4	confirming to Silness and Löe index (Löe \& Silness, 1963)
gingival recession height (GRH)	Change from Baseline to week 4	as the measurement of the distance between the marginal gingiva and cemento-enamel junction
plaque index	Change from Baseline to week 4	in accordance with the Sillness and Löe index (Silness \& Löe, 1964)
bleeding on probing (BOP)	Change from Baseline to week 4	according to Ainoma and Bay (AINAMO \& Bay, 1975);
Probing depth (PD)	Change from Baseline to week 4	as the measurement of the length between the bottom of the periodontal pocket to marginal gingiva;
clinical attachment level (CAL)	Change from Baseline to week 4	as the sum of gingival recession height and probing depth will be recorded.

Secondary Outcome Measures

Name	Time	Method
Changes of Periodontal inflammed surface area	Change from Baseline Baseline to week 4	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.
Changes of Glutathione levels in gingival crevicular fluid	Changes from Baseline to week 1,2,4	The Glutathione activity will be evaluated spectrophotometrically
Changes of Adenosine deaminase (ADA) levels in gingival crevicular fluid	Changes from Baseline to week 1,2,4	The ADA activity will be evaluated spectrophotometrically
Changes of Catalase levels in gingival crevicular fluid	Changes from Baseline to week 1,2,4	The catalase activity will be evaluated spectrophotometrically

Trial Locations

Locations (1)

Van Yuzuncu Yil University Faculty of Dentistry; 🇹🇷 VAN, Turkey