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

Not Applicable

Completed

• Conditions: Pulpitis - Irreversible
• Interventions: Drug: Cataflam® 50 coated tablet; Drug: Limitless Allzyme; Drug: Oral tablets of Alphintern®

• Registration Number: NCT07088042
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-15
• Status Verified: 2025-02
• Primary Completion: 2025-02-17
• Study Completion: 2025-02-17
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Steroidal Anti-inflammatory drug (Cataflam 50mg)	Cataflam® 50 coated tablet	Received Cataflam
Oral Tablets of Limitless Allzyme	Limitless Allzyme	-
Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)	Oral tablets of Alphintern®	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt