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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07088042

Enrollment

Registered

2025-07-28

Start date

2024-09-15

Completion date

2025-02-17

Last updated

2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis - Irreversible

Keywords

premedication, bromelain trypsin chymotrypsin, efficacy of anesthesia

Brief summary

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.

Interventions

DRUGLimitless Allzyme

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

DRUGOral tablets of Alphintern®

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

DRUGCataflam® 50 coated tablet

of Cataflam 50 mg as part of their treatment protocol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026