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NCT Number: NCT06566508

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

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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Key information

Conditions

Intracanal Medication Dental Pulp Diseases Dental Pulp Necrosis Inflammation Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcium Hydroxide Intracanal medication

Drug

Calcium Hydroxide Intracanal medication

Leddermix Intracanal medication

Drug

Leddermix Intracanal medication

Asiaticoside Intracanal medication

Drug

Asiaticoside Intracanal medication

Other names: centella asiatica

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]

    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]

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)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada Abdelrazik

CONTACT

[email protected]

00201003455012

salem alqahtani, master

CONTACT

[email protected]

00201553553096

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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