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NCT Number: NCT07422883

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

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 .

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Key information

Conditions

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university

Al Mansurah, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local application of licorice gel.

Drug

Adequate amount of prepared licorice gel will be inserted into the selected periodontal pockets.

Mechanical Debridement

Other
  • Mechanical debridement will be performed using suitable ultrasonic and hand instruments

Primary outcomes

  1. 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 .

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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