Anesthetic Efficacy of 1.8 ml Versus 3.6 ml of 4% Articaine Buccal Infiltration

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06119139
Collaborator
(none)
70
2
18

Study Details

Study Description

Brief Summary

The aim of the study is to compare the anesthetic efficacy and need for supplemental anesthesia of 1.8 ml compared to 3.6 ml of 4% articaine buccal infiltration in mandibular molars with symptomatic irreversible pulpitis.

Condition or Disease Intervention/Treatment Phase
  • Drug: 3.6 ml 4% Articaine hydrochloride
  • Drug: 1.8 ml 4% Articaine hydrochloride
N/A

Detailed Description

Patients with moderate-to-severe pain due to symptomatic irreversible pulpitis will be included. Patients will be randomly assigned into two groups to receive either 1.8 ml 4% articaine buccal infiltration or 3.6. ml 4% articaine buccal infiltration before single visit root canal treatments. Intraoperative pain will be assessed using an 11-point numerical rating scale (NRS) so that anesthetic success will be defined as no to mild intraoperative pain. The need for supplemental anesthesia will also be recorded.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel, randomized, clinical trialParallel, randomized, clinical trial
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Anesthetic Efficacy of 1.8 ml Compared to 3.6 ml of Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1.8 ml 4% articaine buccal infiltration.

Drug: 1.8 ml 4% Articaine hydrochloride
1.8 ml 4% articaine buccal infiltration

Experimental: 3.6 ml 4% articaine buccal infiltration

Drug: 3.6 ml 4% Articaine hydrochloride
3.6 ml 4% articaine buccal infiltration

Outcome Measures

Primary Outcome Measures

  1. Anesthetic success [During the procedure]

    Will be measured by 11-point numerical rating scale NRS. The success will be defined as no or mild pain (NRS 0 or less than 3) and the failure will be defined as moderate to severe pain (NRS more than 3).

Secondary Outcome Measures

  1. Need for supplemental anesthesia [During the procedure]

    Whether the patient requires supplemental anesthesia or not. It will be recorded by the questionnaire (yes or no).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Healthy patients who are categorized as I or II according to The American Society of Anesthesiologists (ASA class I or II).

  2. No sex predilection

  3. Patients with symptomatic irreversible pulpitis

  4. Patient with the ability to understand and use pain scales.

  5. Patients who accept to enroll in the study.

Exclusion Criteria:
  1. Patients' allergies to any of the drugs or materials used in the study.

  2. Pregnant and lactating females.

  3. Patients taking analgesics in the last 6-8 hours.

  4. Patients having more than one symptomatic tooth in the same quadrant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hebatullah Moheb Ibrahim, Principle investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT06119139
Other Study ID Numbers:
  • CU-Endo.23.10.23
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023