Effectiveness of Oleanolic Acid as Intracanal Medicament on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis

April 11, 2026 updated by: Mansoura University
The objective of this study is to investigate "clinically" the effectiveness of Oleanolic acid based intracanal medicament compared to the commonly used intracanal medicaments (Calcium hydroxide and Ledermix) on the levels of bacteria in root canals and inflammatory cytokines in the periradicular tissues of teeth with apical periodontitis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • 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
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35511
        • 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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Single rooted teeth with pulp necrosis and apical periodontitis.
  2. The age ranges from 20 to 60 years.

Exclusion Criteria:

  1. Patient receiving antibiotic treatment within the preceding 3 months.
  2. Patient reporting systemic disease.
  3. Teeth that can not be isolated with rubber dam.
  4. Teeth with periodontal pockets deeper than 3 mm.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcium hydroxide group
After biomechanical preparation of the canals, calcium hydroxide intracanal medicament will be placed inside the canal for one week before obturation.
Procedure: Root canal treatment
Root canal treatments with administration of intracanal medicaments
Experimental: Ledermix group
After biomechanical preparation of the canals, Ledermix intracanal medicament will be placed inside the canal for one week before obturation.
Procedure: Root canal treatment
Root canal treatments with administration of intracanal medicaments
Experimental: Oleanolic acid group
After biomechanical preparation of the canals, Oleanolic acid intracanal medicament will be placed inside the canal for one week before obturation.
Procedure: Root canal treatment
Root canal treatments with administration of intracanal medicaments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relief of signs and symptoms of apical periodontitis
Time Frame: 1 Week
Absence of discomfort with percussion, Absence of inflammatory exudate from the root canal.
1 Week
Decrease in bacterial count within the root canal.
Time Frame: 1 week
A sample will be taken from the canal to assess the decrease in bacterial count inside the root canal by the effect of intracanal medicament.
1 week
Decrease in interleukin TNF-alpha, IL-1 Beta and PG-E2 in the periapical tissues
Time Frame: 1 week
A sample will be taken from the periapical region to detect the effect of the intracanal medicaments in reducing inflammation and promoting healing in the periapical region.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 11, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M01010024RC

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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