Does Hyaluronic Acid Affect Periodontal Treatment?

Sponsor

Yuzuncu Yıl University (Other)

Overall Status

Completed

CT.gov ID

NCT03754010

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Procedure: Scaling and root planning Drug: Hyaluronic acid gel (HA) and SRP Drug: HA mouthrinse and SRP Drug: HA mouthrinse+gel and SRP	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 30, 2017

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Scaling and root planning (SRP) 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 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.
Experimental: 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.	Procedure: Scaling and root planning 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. Drug: Hyaluronic acid gel (HA) and SRP 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. Other Names: HA and SRP
Experimental: 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.	Procedure: Scaling and root planning 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. Drug: HA mouthrinse and SRP In Group 3, HA hydrogel mouthrinse will be used as an irrigator after SRP. Other Names: HAmo+SRP
Experimental: 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.	Procedure: Scaling and root planning 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. Drug: HA mouthrinse+gel and SRP 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. Other Names: HAmo+HAgel+SRP

Outcome Measures

Primary Outcome Measures

plaque index [Change from Baseline to week 4]
in accordance with the Sillness and Löe index (Silness & Löe, 1964)
gingival index (GI) [Change from Baseline to week 4]
confirming to Silness and Löe index (Löe & Silness, 1963)
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;
gingival recession height (GRH) [Change from Baseline to week 4]
as the measurement of the distance between the marginal gingiva and cemento-enamel junction
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

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 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
Changes of Glutathione levels in gingival crevicular fluid [Changes from Baseline to week 1,2,4]
The Glutathione activity will be evaluated spectrophotometrically

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.