The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain

Symptomatic Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298383
• Other study ID #: ERU1
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: Maha Nasr
• Phone: 01114367063
• Email: maha-nasrmorsi[@]eru.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

Drug:
• Trypsin, Bromelain and Rutoside
Flamogen is a combination of trypsin 48 mgs, bromelain 90mg and rutoside 100 mg in one tablet that provides an anti inflammatory, anti edematous activity. each patient will receive a single dose of 2 tablets one hour before treatment.
• Diclofenac Potassium
Non-steroidal anti inflammatory drug. cataflam is known for its potent anti inflammatory and analgesic properties. each patient will receive one tablet of cataflam 50 mg 1 hour before treatment.
• Prednisolone Oral Tablet
Steroids are potent anti inflammatory drugs, patients are going to receive one tablet of 30 mg solupred one hour before treatment

Other:
• Placebo
A tablet of Compacted powdered milk

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Egyptian Russian University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of Anesthesia	Success of Inferior alveolar Nerve block anesthesia will be measured by recording the patient's pain severity before and after anesthesia administration as well as during endodontic procedures. each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.	through study completion "an average of 1 year"
Primary	Post-operative pain	postoperative pain as recorded by the patient after completion of treatment in on visit.; patient will receive a pain diary to record their postoperative pain incidence and severity at 6, 12, 24, 72 hours and 7 days after endodontic treatment.; Each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.	through study completion "an average of 1 year"