Does Hyaluronic Acid Affect Periodontal Treatment?

November 23, 2018 updated by: Hacer Sahin Aydinyurt, Yuzuncu Yıl University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • VAN, Turkey, 65080
        • Van Yuzuncu Yil University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Investigators

  • Study Director: Hacer Sahin Aydinyurt, Assist Prof, Van Yüzüncü Yil University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 30, 2017

Primary Completion (ACTUAL)

April 30, 2018

Study Completion (ACTUAL)

September 30, 2018

Study Registration Dates

First Submitted

November 15, 2018

First Submitted That Met QC Criteria

November 23, 2018

First Posted (ACTUAL)

November 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 23, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19.07.2017/09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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