Interleukin 6NCT07422883
Assessment of Licorice Extract as an Adjunctive Therapy to Mechanical Debridement in Stage II Periodontitis
A study testing Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local application of licorice gel. and Mechanical Debridement in people with Interleukin 6, run by Mansoura University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Interleukin 6
- What is being tested?
- Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local application of licorice gel. and Mechanical Debridement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 12 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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).
- Conditions
- Interleukin 6
- Being tested
- Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local application of licorice gel., Mechanical Debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 DebridementOther
- Mechanical debridement will be performed using suitable ultrasonic and hand instruments
| Study group | Role | What they receive |
|---|---|---|
| Ten subjects with healthy periodontium will be selected for this group. | No intervention | Not described |
| Mechanical debridement will be performed for 20 stage II periodontitis patients. | Placebo comparator | Not described Receives: Other: Mechanical Debridement |
| Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local ap | Experimental | Not described Receives: Drug: Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local application of licorice gel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the clinical effectiveness of the locally delivered licorice extract gel as an adjunctive therapy to mechanical debridement in Stage II periodontitis patients
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 .
Measured: samples will be collected at Base line then after 3 months by using periopaper strips
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.
Assessment of crevicular fluid IL-6 was based on sandwich enzyme- linked immunosorbent assay (ELISA) technology
Measured: samples are collected at baseline and after 3 months using peiopaper strips
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Feb 2025
- Primary completion15 Jul 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interleukin 6Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed m Anes, Professor, Study director, Faculty of dentistry - Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422883
- Sponsor's protocol ID
- A0204023OM
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Licorice Extract as an Adjunctive Therapy to Mechanical Debridement in Stage II Periodontitis Clinical and Laboratory Study
- ClinicalTrials.gov ID
- NCT07422883
- Acronym / sponsor ID
- A0204023OM
- Conditions
- Interleukin 6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ten subjects with healthy periodontium will be selected for this group. | No intervention | – |
| Mechanical debridement will be performed for 20 stage II periodontitis patients. | Placebo comparator | Other: Mechanical Debridement |
| Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local ap | Experimental | Drug: Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local application of licorice gel. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local ap |
| Mechanical Debridement• Mechanical debridement will be performed using suitable ultrasonic and hand instruments | Other | Mechanical debridement will be performed for 20 stage II periodontitis patients. |
Primary outcome
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 .
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed m Anes, Professor study director
Faculty of dentistry - Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local application of licorice gel. and Mechanical Debridement in people with Interleukin 6, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.