The Effectiveness of Buccal Infiltration Only Using Articaine for Extraction of Mandibular Molar

December 7, 2023 updated by: Albatool Baroom, Riyadh Elm University

The Effectiveness of Buccal Infiltration Only Using Articaine for Routine Exodontia of Mandibular Molar: A Cross-Over Randomized Controlled Clinical Trial

The goal of this clinical trial, is to test out the efficacy of using Articaine only as a local anesthesia as buccal infiltration to extract lower molar teeth.

Study will be performed in patients visiting Riyadh Elm University clinics seeking extraction of lower molars bilaterally, in each visit one molar tooth will be extracted using Ariticaine and the second visit with Lidocaine, pain level will be monitored and documented.

This study may be helpful in providing scientific information to the oral maxillofacial surgeons which will assist them in choosing the best local anesthetic agent, and possibly substituting using inferior alveolar nerve block with infiltration only when extracting the mandibular posterior teeth.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, randomized clinical trial, which will involve 40 patients visiting the out-patient department of Oral and Maxillofacial surgery. For each patient, one mandibular molar will be extracted from right as well as left side, with one side being anesthetized using 4% articaine with 1:100,000 epinephrine and other with 2% lidocaine with 1:100,000 epinephrine buccal infiltration only. Evaluation and comparison will be done on the basis of pain prevalence exhibited by the patients while extraction.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male and female patients
  • Patients with age more than 18 years
  • Patients indicated for at least one mandibular molar extraction
  • Patients with the ability to fill the questionnaire

Exclusion Criteria:

  • Patients with abscess or any lesion, which may affect the local anesthesia provision.
  • Patients with stage III mobile teeth
  • Patients with a history of medical conditions such as diabetes mellitus, heart disease, pregnancy, allergy or renal disease
  • Patients who are not able to give an informed consent or are not agreeing to take part in this study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Right mandibular molar
Articaine 4% with 1:100,000 epinephrine
Drug: Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml
4% articaine with 1:100,000 epinephrine buccal infiltration
Other Names:
  • Septanest
Experimental: Left mandibular molar
Lidocaine 2% with 1:100,000
Drug: Lidocaine 2%/Epi 1:100000 Inj Cart 1.7Ml
2% Lidocaine with 1:100,000 epinephrine buccal infiltration
Other Names:
  • Octocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain measurement
Time Frame: Pain will be measured after injection, during extraction procedure and at the end of the session immediately after finishing the procedure, scale of pain will be 0 for no pain and 10 for maximum pain
Pain will be measured using the vial analogue scale
Pain will be measured after injection, during extraction procedure and at the end of the session immediately after finishing the procedure, scale of pain will be 0 for no pain and 10 for maximum pain

Collaborators and Investigators

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

Sponsor

Riyadh Elm University

Investigators

  • Principal Investigator: Albatool Baroom, Albatool.a.baroom2021@student.riyadh.edu.sa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

November 30, 2023

Primary Completion (Estimated)

April 10, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

November 25, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Estimated)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPGRP/2023/791/1041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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.

Clinical Trials on Pain

Clinical Trials on Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe