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Intracanal MedicationPhase 2/3NCT06453304

Effectiveness of Glycyrrhizin as Intracanal Medication in Root Canal Disinfection and Inflammatory Cytokines

A Phase 2/3 study testing Calcium Hydroxide, Leddermix and Glycirrhizin in people with Intracanal Medication, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Intracanal Medication
What is being tested?
Calcium Hydroxide, Leddermix and Glycirrhizin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteEgypt
Study dates
20 Mar 2022to 10 Jul 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Single-rooted with pulp necrosis and apical periodontitis.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Alaa Eltantawi, phD contact

00201062885600

alaa_reda@mans.edu.eg

Ghada Abdelrazik contact

00201003455012

alaa.92.ar@gmail.com

Egypt1 site, 1 recruiting
  • Alaa Reda Mohamed Eltantawi

    Al Mansurah

    Alaa Eltantawi, phD, 00201062885600, alaa_reda@mans.edu.eg

    Mohamed Asar, 00201069888408, alaa.92.ar@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Clinical Investigation of the Effectiveness of Glycyrrhizin as Intracanal Medication in Root Canal Disinfection and Inflammatory Cytokines

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.

Read the detailed description

Periodontitis is a dynamic inflammatory process located at the periapical region, the type of immune-inflammatory response to periapical periodontitis is determined by a network of chemical mediators produced by immune cells in response to the stimulus caused by the action of microorganisms and/or virulence factors. This may result in damage to the tissues and in the development of endodontic signs and symptoms (1-3).

In infected root canals, the destruction of periapical tissues is mediated by tumor necrotizing factor (TNF-α) and interleukin-1β (IL-1β) that appears to be directly related to high levels of infectious content present in the root canal (4). Arachidonic acid metabolism plays a key role in many inflammatory diseases, one of its products is the prostaglandin E2 (PGE2) which has been also shown to potentially stimulate bone resorption and to inhibit reparative bone formation in vitro and in vivo (5). Particularly, IL-1β, TNF-α, and PGE2 have been detected in periapical tissues (6-9), being considered as an important inflammatory biomarker in the periapical disease (1, 2, 5, 7, 10).

To identify a specific inflammatory mediator as a diagnostic marker of disease status, the mediator should not only be present or elevated in disease and absent or low in health, but it should also longitudinally increase during active disease progression and subside following therapy (5).

Although instrumentation may be assumed to be of greater importance in the clinical practice, the use of intracanal medication has been proven to optimize the root canal disinfection (11-14). As root canal medicaments can come in direct contact with periapical tissues, in addition to having good antibacterial ability and being biocompatible, so a wide variety of intracanal medications have been proposed. In selecting root canal medicaments, it is necessary to consider their therapeutic benefits against their potential cytotoxic effects. Ideal root canal medicaments should have strong antibacterial properties and minimal cytotoxic effect on the host tissues (11-16).

Calcium hydroxide (Ca(OH)2) has been used extensively in dentistry since the 1920s (17). Today, it is still the most commonly used endodontic medicament throughout the world(18).Ca(OH)2 also inactivates lipopolysaccharide so it can assist in periapical tissue repair (19).

Corticosteroids have also shown to interfere with the repair process. This interference includes an inhibition of fibroblastic proliferation and a decrease in polymorphonuclear leukocyte locomotion. In addition, corticosteroids interfere with the immune response, which could disseminate bacteria leading to infectious disease. Considering these potential pitfalls, some investigators have advocated supplemental use of an antibiotic to help control infection. As a result, ledermix paste was used where it consists of both a corticosteroid "triamcinolone" and an antibiotic "dimethyl chlortetracycline" (20, 21).

Herbs have been used in clinical medicine for thousands of years. Recently researchers have been able to employ scientific methods to prove the efficacy of many of these herbs and to provide a better understanding of their mechanisms of action (22).

Glycyrrhiza glabra which is known as licorice belonging to the Fabaceae, is native to southern Europe and parts of Asia including Iran (23). Licorice roots have been used as a remedy for cough, constipation, menopausal hot flashes, peptic ulcer, and viral diseases (24). Licorice contains more than 20 triterpenoids and nearly 300 flavonoids. Among them, glycyrrhizin, 18 β-glycyrrhetinic acid, liquiritigenin, licochalcone A, licochalcone E and glabridin are the main active components which possess antimicrobial, antioxidant and anti-inflammatory activities (25-27). Badr et al. (28) reported that Licorice extract either separately or as Liquorice/Ca(OH)2 mixture had a potent bactericidal effect against Enterococcus faecalis and retained compatibility with fibroblasts in tissue culture compared to the commonly used root canal medicament Ca(OH)2.

Glycyrrhizin (an oleanane-type triterpenoid glucuronide), the main active and important constituent in licorice, is 50 times sweeter than sugar (29) and is used in large quantities as a well-known natural sweetener and as a pharmaceutical (30). It is a conjugate of two molecules of glucuronic acid and glycyrrhetinic acid and is found chiefly in roots and stolons but not in aerial parts (31). Glycyrrhizin possesses anti-allergic (32), anti- diabetic (33), anti-inflammatory (34), anti-ocular hypertension (35), immune-modulatory (36), anti-cholestasis (37), hepatoprotective (38) and neuroprotective pharmacological activities (39). It also has protective effect on the respiratory system (40).

So based on the above mentioned data, it is believed to be of interest to investigate clinically the use of Glycyrrhizin as an intracanal medication.

Being tested
Calcium Hydroxide, Leddermix, Glycirrhizin
Keywords
Glycirrhizin cytokines antibacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calcium HydroxideDrug

    Intracanal medication

  • LeddermixDrug

    Intracanal medication

  • GlycirrhizinDrug

    Intracanal medication

Study groups in NCT06453304
Study groupRoleWhat they receive
Calcium HydroxideActive comparatorNot described
Receives: Drug: Calcium Hydroxide
LeddermixActive comparatorNot described
Receives: Drug: Leddermix
GlycirrhizinActive comparatorNot described
Receives: Drug: Glycirrhizin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. counting the number of colonies forming units of bacterial cells

    Microbiology cell culturing (manual counting technique to the bacterial cells)

    Measured: up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start20 Mar 2022
  3. Primary completion5 Jun 2024
  4. Study completion10 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06453304
Sponsor's protocol ID
Intracanal medication
Status last verified
Jun 2024
First submitted
27 May 2024
Last updated
3 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20728711
  • 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.

    PubMed 17949345
  • 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.

    PubMed 17546863
  • 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.

    PubMed 15533217
  • 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.

    PubMed 20812941
  • 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.

    PubMed 17442017
  • 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.

    PubMed 21496656

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Calcium Hydroxide, Leddermix and Glycirrhizin in people with Intracanal Medication, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alaa Eltantawi, phD (00201062885600, alaa_reda@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

counting the number of colonies forming units of bacterial cells (time frame: up to 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06453304, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

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