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

NCT07534943 | Active Not Recruiting

• 1 other identifier: M01010024RC
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracanal Medicaments; Inflammatory Cytokines; Endodotic Microbiota

Keywords

Intracanal medicaments; Endodontic infections; Inflammatory cytokines

Outcome Measures

Primary Outcomes (3)

• Relief of signs and symptoms of apical periodontitis

  Absence of discomfort with percussion, Absence of inflammatory exudate from the root canal.

  1 Week

• Decrease in bacterial count within the root canal.

  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

  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

Study Arms (3)

Calcium hydroxide group

EXPERIMENTAL

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

Ledermix group

EXPERIMENTAL

After biomechanical preparation of the canals, Ledermix intracanal medicament will be placed inside the canal for one week before obturation.

Procedure: Root canal treatment

Oleanolic acid group

EXPERIMENTAL

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

Interventions

Root canal treatment PROCEDURE

Root canal treatments with administration of intracanal medicaments

Calcium hydroxide group; Ledermix group; Oleanolic acid group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

EG (1)