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

NCT ID: NCT06298383

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2026-01-15

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."

Conditions

Symptomatic Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Trypsin, Bromelain and Rutoside (TBR) Group

patients will receive Trypsin, Bromelain and Rutoside combination (2 tablets of flamogen a combination of Trypsin 48mg, Bromelain 90mg and Rutoside 100mg) as a single oral dose 1 hour before treatment.

Group Type: EXPERIMENTAL

Trypsin, Bromelain and Rutoside

Intervention Type: DRUG

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.

NSAIDs Group

Patients will receive diclofenac potassium (50mg) as a single oral dose 1 hour before treatment.

Group Type: ACTIVE_COMPARATOR

Diclofenac Potassium

Intervention Type: DRUG

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.

Steroid Group

Patients will receive a single oral dose of a steroid drug (30 mg prednisolone) 1 hour before treatment.

Group Type: ACTIVE_COMPARATOR

Prednisolone Oral Tablet

Intervention Type: DRUG

Steroids are potent anti inflammatory drugs, patients are going to receive one tablet of 30 mg solupred one hour before treatment

Placebo group

Patients will receive a single oral dose of placebo (compressed tablets of powdered milk) 1 hour before treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

A tablet of Compacted powdered milk

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Prednisolone Oral Tablet

Steroids are potent anti inflammatory drugs, patients are going to receive one tablet of 30 mg solupred one hour before treatment

Intervention Type: DRUG

Placebo

A tablet of Compacted powdered milk

Intervention Type: OTHER

Other Intervention Names

Flamogen; Cataflam; solupred

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Egyptian Russian University

NETWORK

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Maha Nasr

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha Nasr

Role: PRINCIPAL_INVESTIGATOR

Egyptian Russian University

Locations

Faculty of Oral and Dental Medicine, Egyptian Russian University

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Maha Nasr

Role: CONTACT

maha-nasrmorsi@eru.edu.eg

01114367063

Maha N Abo Shanab

Role: CONTACT

Maha.Nasr@dentistry.cu.edu.eg

01026868266

Facility Contacts

Maha Nasr, PhD

Role: primary

maha-nasrmorsi@eru.edu.eg

00201114367063

Nermine Hassan

Role: primary

maha-nasrmorsi@eru.edu.eg

0020106557670

Other Identifiers

ERU1

Identifier Type: -

Identifier Source: org_study_id