Effectiveness of Asiaticoside as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis

August 20, 2024 updated by: Salem Abdulrahman Alqahtani, Mansoura University
The objective of this study is to investigate "clinically" the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study investigate "clinically" the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Recruiting
        • Mansoura University
        • Contact:
        • Contact:

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:

• 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

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Calcium Hydroxide
Intracanal medication
Drug: Calcium Hydroxide Intracanal medication
Calcium Hydroxide Intracanal medication
Active Comparator: Leddermix
Intracanal medication
Drug: Leddermix Intracanal medication
Leddermix Intracanal medication
Active Comparator: Asiaticoside
Intracanal medication
Drug: Asiaticoside Intracanal medication
Asiaticoside Intracanal medication
Other Names:
  • centella asiatica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
counting the number of colonies forming units of bacterial cells Microbiology cell culturing (manual counting technique to the bacterial cells) [Time Frame: up to 7 months]
Time Frame: up to 7 months
counting the number of colonies forming units of bacterial cells Microbiology cell culturing (manual counting technique to the bacterial cells) [Time Frame: up to 7 months]
up to 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
using enzyme-linked immunosorbent assay (ELISA test) to measure the amount of Inflammatory Cytokines (TNF-α), (IL-1β) and (PG2) ELISA test to measure the amount of tumor necrotizing factor (TNF-α), interleukin 1β(IL-1β) and prostaglandin E2 (PG2)
Time Frame: up to 25 weeks
using enzyme-linked immunosorbent assay (ELISA test) to measure the amount of Inflammatory Cytokines (TNF-α), (IL-1β) and (PG2) ELISA test to measure the amount of tumor necrotizing factor (TNF-α), interleukin 1β(IL-1β) and prostaglandin E2 (PG2)
up to 25 weeks

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Study Director: Youssry Elhawary, prof, Faculty of Dentistry Mansoura University
  • Study Director: Amany Bader, prof, Faculty of Dentistry Mansoura University

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)

November 20, 2023

Primary Completion (Actual)

June 5, 2024

Study Completion (Estimated)

March 3, 2025

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0209023RC

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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