Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis

Study Overview
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Brief Summary
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The study is designed as a randomized parallel controlled trial with three groups. Participants aged above 18 years with the first permanent molars with symptomatic signs of irreversible pulpitis will be randomly assigned into 3 groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block) will be anesthetized using 4% articaine 1:100.000 plus cryotherapy application, and the second group (experimental group) will be anaesthetised with IANB plus buccal infiltration. For the third group (control group), the mandibular molars will be anaesthetized using epinephrine using the inferior alveolar nerve block.

Official Title
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Evaluation of Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Parallel Controlled Trial

Conditions
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Pain, Procedural

Intervention / Treatment
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* Procedure: Cryotherapy
* Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged above 18 years Presence of at least one mandibular first permanent molar, with signs and symptoms of irreversible pulpititis Exclusion Criteria: Participants with a history of taking medications that could interfere with the action of the anaesthetic solutions Presence of paresthesia Presence of psychological problems Taking analgesics or other medications that would alter the inflammatory response of the pulp or provide analgesia 12 h pre-operatively

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryotherapy<br> | Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine<br>* Buccal infiltration after IANB<br>|
| Experimental: IANB plus buccal infiltration local anesthesia<br> | Procedure: Cryotherapy<br>* Ice packs application for 5 minutes after IANB injection<br>|
| Active Comparator: IANB<br> | Procedure: Cryotherapy<br>* Ice packs application for 5 minutes after IANB injection<br>Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine<br>* Buccal infiltration after IANB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | verbal rating scale (VRS) withh the following scores: Score 0: no pain, Score 1: mild pain, Score 2: moderate pain, and Score 3: severe pain. | up to 24 hours |