NCT06453304

Brief Summary

The objective of this study is to investigate "clinically" the effectiveness of Glycyrrhizin 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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

May 27, 2024

Last Update Submit

July 1, 2024

Conditions

Intracanal Medication

Keywords

Glycirrhizin cytokines antibacterial

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)

    up to 7 months

Other Outcomes (1)

  • using enzyme-linked immunosorbent assay (ELISA test) to measure the amount of Inflammatory Cytokines (TNF-α), (IL-1β) and (PG2)

    25 weeks

Study Arms (3)

Calcium Hydroxide

ACTIVE COMPARATOR
Drug: Calcium Hydroxide

Leddermix

ACTIVE COMPARATOR
Drug: Leddermix

Glycirrhizin

ACTIVE COMPARATOR
Drug: Glycirrhizin

Interventions

Calcium HydroxideDRUG

Intracanal medication

Calcium Hydroxide
LeddermixDRUG

Intracanal medication

Leddermix
GlycirrhizinDRUG

Intracanal medication

Glycirrhizin

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Alaa Reda Mohamed Eltantawi

Al Mansurah, Egypt

RECRUITING

Related Publications (7)

  • Martinho FC, Chiesa WM, Leite FR, Cirelli JA, Gomes BP. Antigenic activity of bacterial endodontic contents from primary root canal infection with periapical lesions against macrophage in the release of interleukin-1beta and tumor necrosis factor alpha. J Endod. 2010 Sep;36(9):1467-74. doi: 10.1016/j.joen.2010.06.012.

    PMID: 20728711BACKGROUND

  • Vianna ME, Horz HP, Conrads G, Zaia AA, Souza-Filho FJ, Gomes BP. Effect of root canal procedures on endotoxins and endodontic pathogens. Oral Microbiol Immunol. 2007 Dec;22(6):411-8. doi: 10.1111/j.1399-302X.2007.00379.x.

    PMID: 17949345BACKGROUND

  • Athanassiadis B, Abbott PV, Walsh LJ. The use of calcium hydroxide, antibiotics and biocides as antimicrobial medicaments in endodontics. Aust Dent J. 2007 Mar;52(1 Suppl):S64-82. doi: 10.1111/j.1834-7819.2007.tb00527.x.

    PMID: 17546863BACKGROUND

  • Tang G, Samaranayake LP, Yip HK. Molecular evaluation of residual endodontic microorganisms after instrumentation, irrigation and medication with either calcium hydroxide or Septomixine. Oral Dis. 2004 Nov;10(6):389-97. doi: 10.1111/j.1601-0825.2004.01015.x.

    PMID: 15533217BACKGROUND

  • Badr AE, Omar N, Badria FA. A laboratory evaluation of the antibacterial and cytotoxic effect of Liquorice when used as root canal medicament. Int Endod J. 2011 Jan;44(1):51-8. doi: 10.1111/j.1365-2591.2010.01794.x. Epub 2010 Aug 31.

    PMID: 20812941BACKGROUND

  • van der Sluis LW, Versluis M, Wu MK, Wesselink PR. Passive ultrasonic irrigation of the root canal: a review of the literature. Int Endod J. 2007 Jun;40(6):415-26. doi: 10.1111/j.1365-2591.2007.01243.x. Epub 2007 Apr 17.

    PMID: 17442017BACKGROUND

  • Martinho FC, Chiesa WM, Leite FR, Cirelli JA, Gomes BP. Antigenicity of primary endodontic infection against macrophages by the levels of PGE(2) production. J Endod. 2011 May;37(5):602-7. doi: 10.1016/j.joen.2010.12.005. Epub 2011 Mar 5.

    PMID: 21496656RESULT

MeSH Terms

Interventions

Calcium Hydroxide

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Officials

  • Amany Badr, Prof

    Faculty of Dentistry Mansoura University

    STUDY CHAIR

  • Youssry Elhawary, Prof

    Faculty of Dentistry Mansoura University

    STUDY DIRECTOR

  • Ghada Abdelrazik, Dr

    Faculty of Dentistry Mansoura University

    STUDY DIRECTOR

Central Study Contacts

Alaa Eltantawi, phD

CONTACT

00201062885600alaa_reda@mans.edu.eg

Ghada Abdelrazik

CONTACT

00201003455012alaa.92.ar@gmail.com

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
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 11, 2024

Study Start

March 20, 2022

Primary Completion

June 5, 2024

Study Completion

July 10, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations

EG(1)