Recruiting

Asiaticoside for Apical Periodontitis Intracanal Infections

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What is being tested

Calcium Hydroxide Intracanal medication

+ Leddermix Intracanal medication

+ Asiaticoside Intracanal medication

Drug
Who is being recruted

Dental Pulp Diseases+5

+ Dental Pulp Necrosis

+ Inflammation

From 20 to 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: November 2023
See protocol details

Summary

Principal SponsorMansoura University
Study Contactsalem alqahtani, masterMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 20, 2023

Actual date on which the first participant was enrolled.

This clinical trial aims to assess how well a medication called Asiaticoside works when used inside the root canal of teeth affected by a condition known as apical periodontitis. This condition involves infection and inflammation at the tip of the tooth root, leading to pain and potential tooth loss if untreated. The study compares Asiaticoside to two other common medications, calcium hydroxide and Ledermix, to see which one is better at reducing bacteria and inflammation in the affected teeth. This research is important because finding more effective treatments could improve dental health and outcomes for patients suffering from this painful condition. Participants in the study receive treatment involving the application of the Asiaticoside directly into the root canal of their affected tooth, where it can act on the infection and inflammation. The study evaluates how this treatment impacts the levels of bacteria and inflammatory markers in the tooth and surrounding tissues. By measuring these levels, researchers aim to determine whether Asiaticoside is an effective alternative to current treatments, potentially offering a new way to manage apical periodontitis more effectively.

Official TitleEffectiveness of Asiaticoside as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
NCT06566508
Principal SponsorMansoura University
Study Contactsalem alqahtani, masterMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Dental Pulp DiseasesDental Pulp NecrosisInflammationStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsTooth Diseases

Criteria

Inclusion Criteria: • Single-rooted with pulp necrosis and apical periodontitis. Exclusion Criteria: Receiving antibiotic treatment within the preceding 3 months. * Reporting systemic disease. * Teeth that could not be isolated with rubber dam. * Teeth with periodontal pockets deeper than 3 mm.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Intracanal medication

Group II

Active Comparator
Intracanal medication

Group III

Active Comparator
Intracanal medication

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Mansoura university

Al Mansurah, EgyptOpen Mansoura university in Google Maps
Recruiting
One Study Center