- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07422883
Assessment of Licorice Extract as an Adjunctive Therapy to Mechanical Debridement in Stage II Periodontitis
Assessment of Licorice Extract as an Adjunctive Therapy to Mechanical Debridement in Stage II Periodontitis Clinical and Laboratory Study
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Al Mansurah, Egypt
- Mansoura University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Ten subjects with healthy periodontium will be selected for this group.
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|
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Placebo Comparator: Mechanical debridement will be performed for 20 stage II periodontitis patients.
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• Mechanical debridement will be performed using suitable ultrasonic and hand instruments
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Experimental: Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local ap
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Adequate amount of prepared licorice gel will be inserted into the selected periodontal pockets.
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What is the study measuring?
Primary Outcome Measures
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 .
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samples will be collected at Base line then after 3 months by using periopaper strips
|
Secondary Outcome Measures
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
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Assessment of crevicular fluid IL-6 was based on sandwich enzyme- linked immunosorbent assay (ELISA) technology
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samples are collected at baseline and after 3 months using peiopaper strips
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohamed m Anes, Professor, Faculty of Dentistry - Mansoura University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- A0204023OM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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