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Recruiting NCT06566508

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

Phase II / Phase III Interventional Intracanal Medication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Calcium Hydroxide Intracanal medication, Leddermix Intracanal medication, Asiaticoside Intracanal medication.
Who it may be relevant to
Registry conditions: Intracanal Medication. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Drug Calcium Hydroxide Intracanal medication
    Calcium Hydroxide Intracanal medication
  • Drug Leddermix Intracanal medication
    Leddermix Intracanal medication
  • Drug Asiaticoside Intracanal medication
    Asiaticoside Intracanal medication

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • 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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Mansoura university — Al Mansurah

Identifiers

NCT: NCT06566508 · A0209023RC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗