Intracanal MedicamentsNCT07534943
Effectiveness of Oleanolic Acid as Intracanal Medicament on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
A study testing Root canal treatment in people with Intracanal Medicaments and Inflammatory Cytokines, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracanal Medicaments, Inflammatory Cytokines, Endodotic Microbiota
- What is being tested?
- Root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single rooted teeth with pulp necrosis and apical periodontitis.
- The age ranges from 20 to 60 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Root canal treatment
- Keywords
- Intracanal medicaments, Endodontic infections, Inflammatory cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatmentProcedure or surgery
Root canal treatments with administration of intracanal medicaments
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of signs and symptoms of apical periodontitis
Absence of discomfort with percussion, Absence of inflammatory exudate from the root canal.
Measured: 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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Mar 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracanal MedicamentsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534943
- Sponsor's protocol ID
- M01010024RC
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Oleanolic Acid as Intracanal Medicament on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07534943
- Acronym / sponsor ID
- M01010024RC
- Keywords
- Intracanal medicaments, Endodontic infections, Inflammatory cytokines
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 Apr 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium hydroxide group | Experimental | Procedure: Root canal treatmentAfter biomechanical preparation of the canals, calcium hydroxide intracanal medicament will be placed inside the canal for one week before obturation. |
| Ledermix group | Experimental | Procedure: Root canal treatmentAfter biomechanical preparation of the canals, Ledermix intracanal medicament will be placed inside the canal for one week before obturation. |
| Oleanolic acid group | Experimental | Procedure: Root canal treatmentAfter biomechanical preparation of the canals, Oleanolic acid intracanal medicament will be placed inside the canal for one week before obturation. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Single rooted teeth with pulp necrosis and apical periodontitis.
- The age ranges from 20 to 60 years.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Root canal treatmentRoot canal treatments with administration of intracanal medicaments | Procedure or surgery | Calcium hydroxide group, Ledermix group, Oleanolic acid group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Related InfoLink provided by the sponsor.
Related trials for Intracanal Medicaments
Active, not recruiting
Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
Apical Periodontitis, Root Canal Treatment
Recruiting
Comparison of Postoperative Pain After Double Antibiotic Paste vs Calcium Hydroxide in Teeth With Symptomatic Apical Periodontitis
Symptomatic Apical Periodontitis
Recruiting
The Effect of Different Intracanal Medicaments on Periapical Lesion Healing
Periapical Lesion Healing, Apical Periodontitis
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Removal of Intracanal Medicaments by Different Techniques Using Cone Beam Computed Tomography Analysis
Removal of Intracanal Medication
Recruiting
Postoperative Pain and Substance P Levels After Bioceramic vs Calcium Hydroxide Intracanal Medicaments in Symptomatic Apical Periodontitis
Symptomatic Apical Periodontitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal treatment in people with Intracanal Medicaments and Inflammatory Cytokines, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Relief of signs and symptoms of apical periodontitis (time frame: 1 Week). The study lists 3 primary outcomes in all. 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 16 Apr 2026.