Assessment of Licorice Extract as an Adjunctive Therapy to Mechanical Debridement in Stage II Periodontitis

February 13, 2026 updated by: Mansoura University

Assessment of Licorice Extract as an Adjunctive Therapy to Mechanical Debridement in Stage II Periodontitis Clinical and Laboratory Study

To assess the clinical effectiveness of the locally delivered licorice extract as an adjunctive therapy to mechanical debridement in stage II periodontitis patients. To assess the impact of the locally delivered licorice extract as an adjunctive therapy to mechanical debridement on the level of interleukin-6 in the GCF in stage II periodontitis patients .

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

Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic plaque biofilms and characterized by progressive destruction of the tooth-supporting apparatus. Its primary features include the loss of periodontal tissue support, manifested through gingival bleeding, presence of periodontal pocketing, clinical attachment loss and radiographically assessed alveolar bone loss (1).

Treatment of periodontal disease consists of plaque and calculus removal by scaling and root planing and good oral hygiene. Due to the bacterial etiology and inflammatory pathogenesis of periodontitis, the additional use of local or systemic antimicrobial agents and/or host response modulating agents has been proposed (2).

Locally applied therapy has received considerable attention due to the presence of a site-specific pattern of destruction in periodontal infections. It also provides effective local drug concentrations in the periodontal pocket and avoids potential side effects of systemic antimicrobial agents (2).

Conventional synthetic agents have some potential limitations like extrinsic teeth stains, altered taste sensation, and development of bacterial resistance that hinder its long-term usage (3). Herbal extracts are gaining attention since they contain phytochemicals which are naturally occurring ingredients that can achieve the desired antimicrobial and anti-inflammatory effects (4).

An example of such herb, with significant therapeutic value is "licorice (Glycyrrhiza glabra)". Licorice, is inherent to Mediterranean regions and few parts of Asia. The main active constituent of licorice is Glycyrrhetinic acid (GA), which is obtained from the extract of licorice root. Glycyrrhiza glabra shows anti-inflammatory effects due to the similarity in its chemical structure with glucocorticoids by initiation of glucocorticoid receptor signaling and also by inhibiting the classical complement pathway (5).

Licorice flavonoid components include chalcones, flavones, and isoflavones, which show antimicrobial (6), antiviral (7), anti-inflammatory (8), antidiabetic, antitumor, immunoregulatory (9), hepatoprotective (10) and neuroprotective activities (11).

The advantageous properties of licorice can be ascribed to several mechanisms. In vitro studies have established that licorice prevents cyclooxygenase activity and prostaglandin synthesis as well as indirect inhibition of platelet aggregation and all components in the inflammatory cascade (8). Licorice components possess important antioxidant properties. At the area of inflammation, licorice prevents the neutrophils from producing reactive oxygen species (12). Bioactive phytoconstituents of G. glabra inhibit the growth of periodontopathogens and reduce the inflammatory markers at the site of infection (13). It also ceases osteoclastic activity that contributes to alveolar bone destruction in periodontitis and promote the synthesis of osteoblasts for new bone formation (13).

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.
50

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.
  • Not Applicable

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

  • Egypt
      • Al Mansurah, Egypt
        • Mansoura University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with Stage II Periodontitis (mainly horizontal bone loss with maximum probing depth ≤ 5 mm and with 3-4 mm clinical attachment loss).
  • Age range (30 - 50) years.
  • Good compliance with the plaque control instructions following initial therapy.
  • Availability for follow up and maintenance program.

Exclusion Criteria:

  • Smoking.
  • Systemic diseases which could influence the outcome of the therapy (According to Cornell Medical Index-Health Questionnaire).
  • Pregnant and lactating females.
  • Vulnerable groups of patients' e.g (prisoners, disabled patients and decisionally impaired individuals).

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: Parallel Assignment
  • Masking: Single

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.
No Intervention: Ten subjects with healthy periodontium will be selected for this group.
Placebo Comparator: Mechanical debridement will be performed for 20 stage II periodontitis patients.
Other: Mechanical Debridement
• Mechanical debridement will be performed using suitable ultrasonic and hand instruments
Experimental: Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local ap
Drug: Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local application of licorice gel.
Adequate amount of prepared licorice gel will be inserted into the selected periodontal pockets.

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
To assess the clinical effectiveness of the locally delivered licorice extract gel as an adjunctive therapy to mechanical debridement in Stage II periodontitis patients
Time Frame: samples will be collected at Base line then after 3 months by using periopaper strips
Patients diagnosed with periodontitis underwent meticulous full-mouth debridement in a single session using ultrasonic scalers and site-specific Gracey curettes. All participants were instructed to maintain optimal oral hygiene practices without any additional prescribed therapeutic agents during the study.In the study group, a standardized licorice extract gel containing 5% glycyrrhizin was applied to selected periodontal pockets. These targeted sites were gently irrigated with normal saline and left for 10 minutes to achieve hemostasis. The gel was then applied using a plastic syringe fitted with a wide-gauge needle to facilitate effective delivery . After proper isolation, the needle tip was inserted into the base of the pocket, and the gel was dispensed slowly while gradually withdrawing the needle to ensure uniform distribution along the pocket depth. This application was repeated twice weekly for six weeks, after ensuring the absence of local deposits on the treated tooth .
samples will be collected at Base line then after 3 months by using periopaper strips

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
To assess the impact of the locally delivered licorice extract gel as an adjunctive therapy to mechanical debridement on the level of IL-6 in the GCF in Stage II periodontitis patients.
Time Frame: samples are collected at baseline and after 3 months using peiopaper strips
Assessment of crevicular fluid IL-6 was based on sandwich enzyme- linked immunosorbent assay (ELISA) technology
samples are collected at baseline and after 3 months using peiopaper strips

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.
Mansoura 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: Mohamed m Anes, Professor, Faculty of Dentistry - Mansoura University

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.
February 1, 2025

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.
July 15, 2025

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.
August 12, 2025

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).
January 29, 2026

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.
February 13, 2026

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.
February 20, 2026

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.
February 20, 2026

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.
February 13, 2026

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.
January 1, 2026

More Information

Terms related to this study

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.
  • A0204023OM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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