CClinicalTrials.gg
Active, not recruitingNCT07534943Updated Apr 16, 2026

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

An interventional study of Root canal treatment in Intracanal Medicaments, Inflammatory Cytokines and Endodotic Microbiota, sponsored by Mansoura University. Active, not recruiting at 1 site in Egypt. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intracanal Medicaments
  • Inflammatory Cytokines
  • Endodotic Microbiota

Keywords

  • Intracanal medicaments
  • Endodontic infections
  • Inflammatory cytokines
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • ProcedureRoot canal treatment

    Root canal treatments with administration of intracanal medicaments

06

What researchers measure

Primary outcomes

  1. Relief of signs and symptoms of apical periodontitis

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

    Time frame: 1 Week

  2. 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.

    Time frame: 1 week

  3. 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.

    Time frame: 1 week

07

Study locations

1 site
  • Mansoura University
    Al Mansurah, Dakahlia Governorate 35511, Egypt
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07534943
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Apr 16, 2026
Start date
Mar 1, 2026
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Apr 16, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion