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

NCT06566508 — Phase 2 / Phase 3, Unknown, 36 participants, Mansoura University

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Registry	NCT06566508
Status	Unknown
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, crossover, masking: double, treatment
Enrollment	36 (Estimated)
Sponsor	Mansoura University (Other)
Conditions	Intracanal Medication
Interventions	Calcium Hydroxide Intracanal medication, Leddermix Intracanal medication, Asiaticoside Intracanal medication (Drug)
Dates	start 2023-11-20, primary completion 2024-06-05, completion 2025-03-03 (estimated), first posted 2024-08-22, last updated 2024-08-22
Locations	1 site in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Calcium Hydroxide	Active comparator	Drug: Calcium Hydroxide Intracanal medication	Intracanal medication
Leddermix	Active comparator	Drug: Leddermix Intracanal medication	Intracanal medication
Asiaticoside	Active comparator	Drug: Asiaticoside Intracanal medication	Intracanal medication

Calcium Hydroxide Intracanal medication (Drug): Calcium Hydroxide Intracanal medication
Leddermix Intracanal medication (Drug): Leddermix Intracanal medication
Asiaticoside Intracanal medication (Drug), also known as centella asiatica: Asiaticoside Intracanal medication

+Outcome measures

Primary outcomes

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 outcomes

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)

+Eligibility

Sex: All, ages: 20 Years to 60 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Mansoura university	Al Mansurah	Egypt	Recruiting

+Investigators

Amany Bader, prof, Study director, Faculty of Dentistry Mansoura University
Youssry Elhawary, prof, Study director, Faculty of Dentistry Mansoura University