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

June 16, 2022 updated by: Ahmad Elheeny, Minia University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: up to 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2022

Primary Completion (Anticipated)

June 18, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 602

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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