Effectiveness of Asiaticoside as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2024
CompletedFirst Submitted
Initial submission to the registry
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2025
CompletedAugust 22, 2024
August 1, 2024
7 months
August 20, 2024
August 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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]
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 Outcomes (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)
up to 25 weeks
Study Arms (3)
Calcium Hydroxide
ACTIVE COMPARATORIntracanal medication
Leddermix
ACTIVE COMPARATORIntracanal medication
Asiaticoside
ACTIVE COMPARATORIntracanal medication
Interventions
Asiaticoside Intracanal medication
Eligibility Criteria
You may qualify if:
- Single-rooted with pulp necrosis and apical periodontitis.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university
Al Mansurah, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amany Bader, prof
Faculty of Dentistry Mansoura University
- STUDY DIRECTOR
Youssry Elhawary, prof
Faculty of Dentistry Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 22, 2024
Study Start
November 20, 2023
Primary Completion
June 5, 2024
Study Completion
March 3, 2025
Last Updated
August 22, 2024
Record last verified: 2024-08