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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Pulpitis - Irreversible

Treatments: Drug: Oral tablets of Alphintern®; Drug: Limitless Allzyme; Drug: Cataflam® 50 coated tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT07088042

FDASU-RecIM012370

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

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

Active Comparator group

Description:

Received Cataflam

Treatment:

Drug: Cataflam® 50 coated tablet

Inferior alveolar nerve block only

No Intervention group

Description:

received Inferior alveolar nerve block only

Oral Tablets of Limitless Allzyme

Experimental group

Treatment:

Drug: Limitless Allzyme

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

Active Comparator group

Treatment:

Drug: Oral tablets of Alphintern®