Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453304
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-27
Brief Title:
Effectiveness of Glycyrrhizin as Intracanal Medication in Root Canal Disinfection and Inflammatory Cytokines
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Clinical Investigation of the Effectiveness of Glycyrrhizin as Intracanal Medication in Root Canal Disinfection and Inflammatory Cytokines
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CaOH2 and Ledermix on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis
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 andor 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 CaOH2 has been used extensively in dentistry since the 1920s 17 Today it is still the most commonly used endodontic medicament throughout the world18CaOH2 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 LiquoriceCaOH2 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 CaOH2
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
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 CaOH2 has been used extensively in dentistry since the 1920s 17 Today it is still the most commonly used endodontic medicament throughout the world18CaOH2 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 LiquoriceCaOH2 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 CaOH2
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None