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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuzuncu Yıl University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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