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

NCT07088042 | Completed Phase 4

• 1 other identifier: FDASU-RecIM012370
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis - Irreversible

Keywords

premedication; bromelain trypsin chymotrypsin; efficacy of anesthesia

Outcome Measures

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

  Assessment of outcome is done using cavity test.

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

Study Arms (4)

Non-Steroidal Anti-inflammatory drug (Cataflam 50mg)

ACTIVE COMPARATOR

Received Cataflam

Drug: Cataflam® 50 coated tablet

Inferior alveolar nerve block only

NO INTERVENTION

received Inferior alveolar nerve block only

Oral Tablets of Limitless Allzyme

EXPERIMENTAL

Drug: Limitless Allzyme

Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)

ACTIVE COMPARATOR

Drug: Oral tablets of Alphintern®

Interventions

Limitless Allzyme DRUG

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

Oral Tablets of Limitless Allzyme

Oral tablets of Alphintern® DRUG

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

Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)

Cataflam® 50 coated tablet DRUG

of Cataflam 50 mg as part of their treatment protocol

Non-Steroidal Anti-inflammatory drug (Cataflam 50mg)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt, 4470351, Egypt

Location

Related Publications (1)

• Hashem AAR, Abd El Sattar AA, Abdel Rahman TY. The Effect of Trypsin-Chymotrypsin on Postoperative Pain after Single Visit Endodontic Treatment: A Randomized Controlled Trial. J Endod. 2023 Mar;49(3):240-247. doi: 10.1016/j.joen.2022.12.010. Epub 2022 Dec 24.

  PMID: 36574828 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: July 28, 2025
• Study Start: September 15, 2024
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)