Clinical trial NCT06298383: The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Egyptian Russian University
First posted: 2024-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 e.g., 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."

Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic irreversible pulpitis.
* Patients with active pain (moderate-to-severe) in mandibular molars.
* Males and females.
* Patient with the ability to understand and use pain scales.
* Patient who accepts to enroll to the study

Exclusion Criteria:

* Patients' allergies or any other contraindication to any of the used medications or mepivacaine.
* Pregnant and lactating females.
* Patients have been taking pain medication 12 hours earlier.
* Patient has more than one symptomatic mandibular tooth in the same quadrant.
* Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
* Patients with contributory medical history (ASA\>II).

Primary outcomes:
measure: Success of Anesthesia
timeFrame: through study completion "an average of 1 year"
measure: Post-operative pain
timeFrame: through study completion "an average of 1 year"
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine, Egyptian Russian University
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Egyptian Russian University
name: Maha Nasr
role: PRINCIPAL_INVESTIGATOR
References: