Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298383
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-19
Brief Title:
The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
The Effect of Premedication With Trypsin Bromelain and Rutoside Combination on the Success of IAN Block and Post Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Pain is a very important factor in Endodontic treatment Both intra- and Post-operatively In case of symptomatic Irreversible pulpitis a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity therefore a number of pre- medications was suggested with variable success rates Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids
Detailed Description:
Background and Rationale
Successful pain management during root canal treatment is crucial for both patients and endodontists For patients with irreversible pulpitis achieving adequate pulpal anesthesia during endodontic therapy is a major concern posing a considerable difficulty from a clinical point of view as an inadequately anesthetized hot tooth with severe pain will not only elevate the patients apprehension but will also stress the practicing clinician Inferior alveolar nerve block IANB technique is commonly used to achieve pulpal anesthesia in mandibular teeth Studies reported that the failure ratio of a single IANB block injection of local anesthetic in patients with irreversible pulpitis ranges between 30 and 90 Efforts have been made to explain the mechanisms of IANB failure including anatomic variations eg cross innervations and accessory innervations decreased local pH tachyphylaxis of anesthetic solutions and activation of nociceptors like tetrodotoxin TTX Several clinical studies identified inflammation as a major cause of failure of local anesthesia and an important component of the pathogenesis of hyperalgesia The use of both steroidal and nonsteroidal anti-inflammatory drugs NSAIDs was investigated to improve the success rates of IANB anesthesia The use of NSAIDs aimed at reducing the chemical inflammatory mediators that activate or sensitize peripheral nociceptors and the related subsequent events involved in pain perception Because NSAIDs reduce nociceptor activation by decreasing the levels of inflammatory mediators it is hypothesized that premedication with NSAIDs could affect the success rate of local anesthesia in patients with irreversible pulpitis Therefore administration of preoperative NSAIDs to increase the success rate of mandibular molars anesthesia has been studied
Since both steroidal and NSAID medications are associated with significant side effects there is a great deal of interest in natural compounds which have been used for centuries to reduce pain and inflammation Systemic enzyme therapy refers to the use of proteolytic hydrolytic enzymes also called proteases which are naturally occurring substances derived from animal or plant sources Though proteases are mostly known for their role in digestion they are necessary for some critical processes in the body like protein recycling immune function cell division and blood clotting In our body these proteases are produced by the stomach and the pancreases but they are also available in plant and animal sources The role of proteases is commonly thought of as degradative but they also contribute to effective immune responses by conveying hormone-like signals and intracellular signal transduction via the specific cell surface receptors Some of the popular enzymes and their combinations are trypsin-chymotrypsin bromelain and papain Combined with the bioflavonoid rutin Rutoside the proteases Trypsin and Bromelain have been extensively investigated as alternatives to conventional therapies for pain and swelling associated with diverse conditions
The aim of the trial To assess the effect of Trypsin Bromelain and Rutoside combination versus ibuprofen or dexamethasone or placebo on the anesthetic success of IANB and postoperative pain in patients with symptomatic irreversible pulpitis
The null hypothesis tested is In patients with symptomatic irreversible pulpitis in their mandibular molars there is no difference between Trypsin Bromelain and Rutoside combination or ibuprofen or dexamethasone or placebo on anesthetic success and post-operative pain after endodontic treatment
Successful pain management during root canal treatment is crucial for both patients and endodontists For patients with irreversible pulpitis achieving adequate pulpal anesthesia during endodontic therapy is a major concern posing a considerable difficulty from a clinical point of view as an inadequately anesthetized hot tooth with severe pain will not only elevate the patients apprehension but will also stress the practicing clinician Inferior alveolar nerve block IANB technique is commonly used to achieve pulpal anesthesia in mandibular teeth Studies reported that the failure ratio of a single IANB block injection of local anesthetic in patients with irreversible pulpitis ranges between 30 and 90 Efforts have been made to explain the mechanisms of IANB failure including anatomic variations eg cross innervations and accessory innervations decreased local pH tachyphylaxis of anesthetic solutions and activation of nociceptors like tetrodotoxin TTX Several clinical studies identified inflammation as a major cause of failure of local anesthesia and an important component of the pathogenesis of hyperalgesia The use of both steroidal and nonsteroidal anti-inflammatory drugs NSAIDs was investigated to improve the success rates of IANB anesthesia The use of NSAIDs aimed at reducing the chemical inflammatory mediators that activate or sensitize peripheral nociceptors and the related subsequent events involved in pain perception Because NSAIDs reduce nociceptor activation by decreasing the levels of inflammatory mediators it is hypothesized that premedication with NSAIDs could affect the success rate of local anesthesia in patients with irreversible pulpitis Therefore administration of preoperative NSAIDs to increase the success rate of mandibular molars anesthesia has been studied
Since both steroidal and NSAID medications are associated with significant side effects there is a great deal of interest in natural compounds which have been used for centuries to reduce pain and inflammation Systemic enzyme therapy refers to the use of proteolytic hydrolytic enzymes also called proteases which are naturally occurring substances derived from animal or plant sources Though proteases are mostly known for their role in digestion they are necessary for some critical processes in the body like protein recycling immune function cell division and blood clotting In our body these proteases are produced by the stomach and the pancreases but they are also available in plant and animal sources The role of proteases is commonly thought of as degradative but they also contribute to effective immune responses by conveying hormone-like signals and intracellular signal transduction via the specific cell surface receptors Some of the popular enzymes and their combinations are trypsin-chymotrypsin bromelain and papain Combined with the bioflavonoid rutin Rutoside the proteases Trypsin and Bromelain have been extensively investigated as alternatives to conventional therapies for pain and swelling associated with diverse conditions
The aim of the trial To assess the effect of Trypsin Bromelain and Rutoside combination versus ibuprofen or dexamethasone or placebo on the anesthetic success of IANB and postoperative pain in patients with symptomatic irreversible pulpitis
The null hypothesis tested is In patients with symptomatic irreversible pulpitis in their mandibular molars there is no difference between Trypsin Bromelain and Rutoside combination or ibuprofen or dexamethasone or placebo on anesthetic success and post-operative pain after endodontic treatment
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