Does Hyaluronic Acid Affect Periodontal Treatment?

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754010
• Other study ID #: 19.07.2017/09
• Status: Completed
• Phase: Phase 1
• Start date: August 30, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: November 2018
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.
• HA mouthrinse and SRP
In Group 3, HA hydrogel mouthrinse will be used as an irrigator after SRP.
• 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.

Locations

Country	Name	City	State
Turkey	Van Yuzuncu Yil University Faculty of Dentistry	VAN

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plaque index	in accordance with the Sillness and Löe index (Silness & Löe, 1964)	Change from Baseline to week 4
Primary	gingival index (GI)	confirming to Silness and Löe index (Löe & Silness, 1963)	Change from Baseline to week 4
Primary	bleeding on probing (BOP)	according to Ainoma and Bay (AINAMO & Bay, 1975);	Change from Baseline to week 4
Primary	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
Primary	gingival recession height (GRH)	as the measurement of the distance between the marginal gingiva and cemento-enamel junction	Change from Baseline to week 4
Primary	clinical attachment level (CAL)	as the sum of gingival recession height and probing depth will be recorded.	Change from Baseline to week 4
Secondary	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
Secondary	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
Secondary	Changes of Catalase levels in gingival crevicular fluid	The catalase activity will be evaluated spectrophotometrically	Changes from Baseline to week 1,2,4
Secondary	Changes of Glutathione levels in gingival crevicular fluid	The Glutathione activity will be evaluated spectrophotometrically	Changes from Baseline to week 1,2,4