NCT07422883

Brief 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 GCF in stage II periodontitis patients .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
Last Updated

February 20, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 29, 2026

Last Update Submit

February 13, 2026

Conditions

Outcome Measures

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

    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 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.

    samples are collected at baseline and after 3 months using peiopaper strips

Study Arms (3)

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.

Interventions

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

Mechanical debridement will be performed for 20 stage II periodontitis patients followed by local ap

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

Mechanical debridement will be performed for 20 stage II periodontitis patients.

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Egypt

Location

Study Officials

  • Mohamed m Anes, Professor

    Faculty of dentistry - Mansoura university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 20, 2026

Study Start

February 1, 2025

Primary Completion

July 15, 2025

Study Completion

August 12, 2025

Last Updated

February 20, 2026

Record last verified: 2026-01

Locations