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

Phase 2

Recruiting

• Conditions: Intracanal Medication
• Interventions: Drug: Leddermix Intracanal medication; Drug: Asiaticoside Intracanal medication; Drug: Calcium Hydroxide Intracanal medication

• Registration Number: NCT06566508
• Lead Sponsor: Mansoura University

Brief Summary

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.

Study Timeline

• Study Start: 2023-11-20
• Primary Completion: 2024-06-05
• Status Verified: 2024-08
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Study Completion: 2025-03-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Leddermix	Leddermix Intracanal medication	Intracanal medication
Asiaticoside	Asiaticoside Intracanal medication	Intracanal medication
Calcium Hydroxide	Calcium Hydroxide Intracanal medication	Intracanal medication

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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)

Trial Locations

Locations (1)

Mansoura university; 🇪🇬 Mansoura, Egypt