Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466538
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-08
Brief Title:
InvestigateClinically the Effectiveness of Boswellia Based Intracanal Medication Compared to Calcium Hydroxide CaOH2 and Ledermix on the Levels of Bacteria and Inflammatory Cytokines in Root Canals and Periradicular Tissues of Teeth With Apical Periodontitis
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Effectiveness of Boswellia as Intracanal Medication on InfectiousInflammatory Contents in Teeth With Apical Periodontitis
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 Boswellia 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:
Apical periodontitis is an inflammatory disorder of the periradicular tissue caused by bacterial infection of endodontic origin which is characterized by periapical bone resorption Primary endodontic disease has a polymicrobial etiology with predominance of Gram-negative anaerobic bacteria This species presents lipopolysaccharides LPSs one of the most important inflammatory molecules present in the outer layer of its membrane which can be released during multiplication or bacterial death thus continuously stimulating the surrounding tissues even at low levels
Endotoxins have been detected in 100 of the primarily infected root canals with high levels being related to more severe inflammatory response in periapical tissues When bacteria and their toxins eg LPS present in the root canal infection egress into the periapical tissues via apical foramen they activate immune response locally culminating in a very complex inflammatory disorder involving a variety of inflammatory cells as well as different proinflammatory cytokines IL-1β TNF-α and PGE2 have been detected in periapical tissues being considered important inflammatory biomarkers in the apical disease Since bacteria and their by-products are one of the main causes of apical periodontitis special emphasis is given to the search for an optimal root canal disinfection protocol
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 For this reason a wide variety of intracanal medications have been proposed Calcium hydroxide CaOH2 is the most commonly used intracanal medication Lately chlorhexidine CHX has emerged as a potential intracanal medication and suggested to be used alone or combined with CaOH2 in a paste Although studies have investigated the antibacterial property of CaOH2 including CHX associations the effects on immune periapical response is incipient
Another effective intracanal medication is Ledermix which contains 1 triamcinolone TAA and 3 demeclocycline DOC This formulation was first recommended for use in endodontics The use of Ledermix appear to be more likely related to the anti-inflammatory effects of corticosteroid rather than its antibacterial effect The antibiotic component does not appear to be ideal and the use of other antibiotics may help to improve the antimicrobial effects of Ledermix
Because root canal medicaments can come in contact with periapical tissue in addition to having good antibacterial ability they must also be biocompatible 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 Herbs have been used in clinical medicine for thousands of years However it is only in recent times that 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 Graf 2000
Ayurveda Indian traditional medicine practice used Boswellia for the treatment of gastrointestinal diseases such as diarrhea constipation flatulence and vomiting It was also stated that the extract is useful in the treatment for diabetic patients and also for respiratory complications including cough cold hoarseness bronchitis asthma and dyspnea
So based on the above mentioned data it is believed to be of interest to investigate clinically the use of Boswellia as an intracanal medication
Endotoxins have been detected in 100 of the primarily infected root canals with high levels being related to more severe inflammatory response in periapical tissues When bacteria and their toxins eg LPS present in the root canal infection egress into the periapical tissues via apical foramen they activate immune response locally culminating in a very complex inflammatory disorder involving a variety of inflammatory cells as well as different proinflammatory cytokines IL-1β TNF-α and PGE2 have been detected in periapical tissues being considered important inflammatory biomarkers in the apical disease Since bacteria and their by-products are one of the main causes of apical periodontitis special emphasis is given to the search for an optimal root canal disinfection protocol
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 For this reason a wide variety of intracanal medications have been proposed Calcium hydroxide CaOH2 is the most commonly used intracanal medication Lately chlorhexidine CHX has emerged as a potential intracanal medication and suggested to be used alone or combined with CaOH2 in a paste Although studies have investigated the antibacterial property of CaOH2 including CHX associations the effects on immune periapical response is incipient
Another effective intracanal medication is Ledermix which contains 1 triamcinolone TAA and 3 demeclocycline DOC This formulation was first recommended for use in endodontics The use of Ledermix appear to be more likely related to the anti-inflammatory effects of corticosteroid rather than its antibacterial effect The antibiotic component does not appear to be ideal and the use of other antibiotics may help to improve the antimicrobial effects of Ledermix
Because root canal medicaments can come in contact with periapical tissue in addition to having good antibacterial ability they must also be biocompatible 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 Herbs have been used in clinical medicine for thousands of years However it is only in recent times that 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 Graf 2000
Ayurveda Indian traditional medicine practice used Boswellia for the treatment of gastrointestinal diseases such as diarrhea constipation flatulence and vomiting It was also stated that the extract is useful in the treatment for diabetic patients and also for respiratory complications including cough cold hoarseness bronchitis asthma and dyspnea
So based on the above mentioned data it is believed to be of interest to investigate clinically the use of Boswellia 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