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Completed

NCT Number: NCT07088042

Assessment of Different Medications in Modifying the Efficacy of Anesthesia in Mandibular Molars With Acute Irreversible Pulpitis

The goal of this clinical trial is to assess the effect of preoperative

* Oral Tablets of Trypsin/Chymotrypsin/Bromelain Limitless Allzyme® (15 microkatal/42microkatal/240 GDU) * Oral tablets of Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals) * Oral Tablets Non-Steroidal Anti-inflammatory drug (Cataflam® 50mg)

Regarding the efficacy of the inferior alveolar nerve block anesthesia in mandibular molars with symptomatic irreversible pulpitis and post operative pain follow up for 3 days.

The main question it aims to answer are: • Does premedication increase the success rate of inferior alveolar nerve block.

Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment. Researchers will compare different premedication to see if it increases the success rate of inferior alveolar nerve block using Visual Analogue Scale (VAS), Electric Pulp testing and cavity test.

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Key information

Conditions

Pulpitis - Irreversible

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, Egypt, 4470351

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • From 18 to 65 years old.
  • Both male and female participants were accepted.
  • Mandibular molars diagnosed with acute irreversible pulpitis.
  • Class I occlusion with normal occlusal contacts

Exclusion criteria

  • • Individuals with significant health issues: a history of gastrointestinal disorders, active bronchial asthma, renal diseases, liver dysfunction, heart diseases, blood disorders, hypertension or poorly controlled diabetes mellitus.
  • Immunocompromised patients.
  • Sensitivity or allergy to any of the pharmaceuticals or medications intended for use in the study
  • Participants who could not read, comprehend, or complete the baseline pain scale questionnaire.
  • Cases where clinical examination suggested necrotic teeth leading to a false positive diagnosis.
  • Teeth exhibiting periodontal disease or periapical lesions confirmed through clinical assessment and pre-operative radiographs.
  • Sensitivity to percussion or palpation in the included teeth

Treatment and study plan

Limitless Allzyme

Drug

Received Limitless Allzyme Max® Trypsin/Chymotrypsin/Bromelain(15 microkatal/42microkatal/240 GDU)

Oral tablets of Alphintern®

Drug

received (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)

Cataflam® 50 coated tablet

Drug

of Cataflam 50 mg as part of their treatment protocol

Primary outcomes

  1. assess the effect of Preoperative administration of- Oral tablets of Trypsin/Chymotrypsin/Bromelain) - Regarding the efficacy of the inferior alveolar nerve block anesthesia in mandibular molars with symptomatic irreversible pulpitis

    Time frame: Up to 30 minutes from lip numbness until the end of pulp exacerbation and post operative pain follow up for 3 days.

    Assessment of outcome is done using cavity test.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

"Assessment of Different Medications in Modifying the Efficacy of Anesthesia in Mandibular Molars With Acute Irreversible Pulpitis (A Randomized Clinical Trial)"

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

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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