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NCT05427903 Clinical Trial

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

Pain, Procedural Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05427903
Other study ID # 602
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 4, 2022
Est. completion date July 1, 2022

Study information
Verified date June 2022
Source Minia University
Contact Ahmad Elheeny, PhD
Phone 00201064257135
Email ahmedelheeny@mu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date July 1, 2022
Est. primary completion date June 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cryotherapy
Ice packs application for 5 minutes after IANB injection
• Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine
Buccal infiltration after IANB

Locations
Country Name City State
Egypt Minia University Minya

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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