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Completed

NCT Number: NCT06298383

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine, Egyptian Russian University, Cairo, Cairo Governorate, Egypt

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About this study

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 diclofenac potassium or prednisolone 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 diclofenac potassium or prednisolone or placebo on anesthetic success and post-operative pain after endodontic treatment."

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Trypsin, Bromelain and Rutoside

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.

Other names: Flamogen

Diclofenac Potassium 50mg Tab

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.

Prednisolone Oral Tablet

Drug

Steroids are potent anti inflammatory drugs, patients are going to receive one tablet of 20 mg solupred one hour before treatment

Other names: solupred

Placebo

Other

An opaque white capsule filled with starch

Primary outcomes

  1. Success of Anesthesia

    Time frame: Perioperative

    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.

  2. Post-operative pain

    Time frame: Each patient will deliver his/her pain diary one week after root canal treatment

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Egyptian Russian University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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