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

Cairo University (CU)

Status

Completed

Conditions

Symptomatic Irreversible Pulpitis

Treatments

Drug: Trypsin, Bromelain and Rutoside

Drug: Diclofenac Potassium

Drug: Prednisolone Oral Tablet

Other: Placebo

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT06298383

ERU1

Details and patient eligibility

About

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.

Full description

Background and Rationale

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. The failure rates of a single IANB block injection of local anesthetic in patients with irreversible pulpitis range between 30 and 90 %.

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. 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."

Enrollment

124 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

124 participants in 4 patient groups, including a placebo group

Trypsin, Bromelain and Rutoside (TBR) Group

Experimental group

Description:

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.

Treatment:

Drug: Trypsin, Bromelain and Rutoside

NSAIDs Group

Active Comparator group

Description:

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

Treatment:

Drug: Diclofenac Potassium

Steroid Group

Active Comparator group

Description:

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