Actively Recruiting

Phase 2
Phase 3
Age: 20Years - 60Years
All Genders
Healthy Volunteers
ID06566508

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

Led by Mansoura University · Updated on 2024-08-22

36

Participants Needed

1

Research Sites

38 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of Asiaticoside as an intracanal medication compared to commonly used treatments like calcium hydroxide and Ledermix in teeth affected by apical periodontitis. The study focuses on measuring bacterial levels and inflammatory cytokines in root canals and surrounding tissues to better understand how these medications impact infection and inflammation in this dental condition. This investigation is conducted as a Phase 2 and Phase 3 clinical trial with a randomized and double-blind design. Participants will receive one of three intracanal medications: Asiaticoside, calcium hydroxide, or Ledermix. These treatments will be applied inside the root canals of single-rooted teeth diagnosed with pulp necrosis and apical periodontitis. The study compares these medications directly to assess their effects on bacteria and inflammatory markers over time. During the study, researchers will count bacterial colonies using microbiology culturing techniques up to seven months after treatment. They will also measure inflammatory cytokines such as tumor necrosis factor, interleukin-1 beta, and prostaglandin E2 using ELISA tests for up to 25 weeks. Participants will be monitored carefully to track changes in infection levels and inflammation, contributing to understanding the treatments' impact. The total participation period spans several months with detailed laboratory evaluations.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Single-rooted tooth with pulp necrosis and apical periodontitis
  • Age between 20 and 60 years
Not Eligible

You will not qualify if you...

  • Receiving antibiotic treatment within the preceding 3 months
  • Having any systemic disease
  • Tooth that cannot be isolated with a rubber dam
  • Presence of periodontal pockets deeper than 3 mm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 7 months

Participants receive intracanal medication with Asiaticoside, Calcium Hydroxide, or Leddermix to treat teeth with apical periodontitis.

Multiple visits for medication administration and assessments over treatment period

Trial Site Locations

Total: 1 location

1

Mansoura university

Al Mansurah, Egypt

Actively Recruiting

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Research Team

S

salem alqahtani, master

G

Ghada Abdelrazik

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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