Buccal Infiltration of Different Volumes of Articaine for Extraction.

Comparing the Effectiveness of Buccal Infiltration of Different Volumes of Articaine for Extraction of Mandibular Posterior Teeth- A Randomized Clinical Trial.

This study compares the effectiveness of two different volumes of buccal infiltration of Articaine for the extraction of mandibular posterior teeth. One group receives buccal infiltration of 1.8 ml of 4% Articaine and the other group receives buccal infiltration of 3.6 ml of 4% Articaine.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Buccal Infiltration; Articaine
• Intervention / Treatment: Other: 3.6 ml of 4% Articaine; Other: 1.8 ml of 4% Articaine

Detailed Description

The most widely and commonly used injection method for the extraction of mandibular posterior teeth is the inferior alveolar nerve block (IANB) technique. However, various complications like pain during injection, transient facial nerve paralysis, trismus, hematoma, and paresthesia are associated with the inferior alveolar nerve block technique.

Local infiltration technique has been proven as a safer and less painful anesthetic injection technique compared to IANB. Unfortunately, the dense nature of cortical bone in the mandibular posterior region hinders sufficient diffusion of anesthetic solution during infiltration. Thus, to achieve an adequate anesthesia for a painless dental extraction of mandibular posterior teeth by infiltration technique, a strong and effective local anesthetic agent having a deeper penetrating property should be used.

Articaine is one of the most widely used local anesthetic agents. It is more potent and has shown more success rate than Lidocaine and Mepivacaine in providing anesthesia in mandibular and maxillary posterior teeth by buccal infiltration diffusibility.

This study compares the effectiveness of two different volumes of buccal infiltration of Articaine for the extraction of mandibular posterior teeth.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Atif S Agwan; Phone Number: 966541651713; Email: m.abdulsaleem@qu.edu.sa
• Study Contact Backup: Name: Abdul K Azad; Phone Number: 00966594914343; Email: a.azad@qu.edu.sa

Study Locations

• Saudi Arabia
  • Buraidah, Saudi Arabia, 52385
    • Recruiting
    • College of Dentistry, Qassim University
    • Contact: Muhammad Atif Agwan; Phone Number: 00966541651713; Email: m.abdulsaleem@qu.edu.sa
  • Al qassim
    • Buraidah, Al qassim, Saudi Arabia, 52719
      • Not yet recruiting
      • Qassim University
      • Contact: Muhammad Atif S Agwan; Phone Number: 966-541651713; Email: m.abdulsaleem@qu.edu.sa
      • Sub-Investigator: Abdullah Ahmad A Aloyouni
      • Sub-Investigator: Abdul K Azad
      • Sub-Investigator: Muhammad Zubair Ahmed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All healthy patients (ASA I) or patients with mild systemic disease with no functional limitations (ASA II)
• Patients aged ≥ 18 years of age.
• Patients requiring extraction of mandibular posterior teeth including grossly decayed tooth, grade I mobile tooth, root stumps and indicated for therapeutic reasons.
• Patients not allergic to the drugs or anesthetic agents used in the surgery.

Exclusion Criteria:

• Acute infection at the extraction site.
• Patients indicated for surgical extraction of teeth.
• Patients already taking medications affecting pain assessment.
• Pregnant patients.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Buccal infiltration of 3.6 ml of 4% Articaine	Other: 3.6 ml of 4% Articaine; Buccal infiltration of 3.6 ml of 4% Articaine.
Active Comparator: Group B; Buccal infiltration of 1.8 ml of 4% Articaine	Other: 1.8 ml of 4% Articaine; Buccal infiltration of 1.8 ml of 4% Articaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain	VAS scale is a validated scale measuring pain with possible score range from 0 (no pain) to 100 (severe pain).	From reflection of mucoperiosteum till delivery of tooth out of socket.
Time of onset of anesthesia	It will be assessed by probing buccal and lingual soft tissue using a dental explorer every 2 minutes after infiltration using a standard digital stop clock.	upto 10 minutes
Presence or absence of pain	A 100 mm Numerical rating scale assessing intraoperative pain. Possible score ranges from 0 (no pain) to 100 (worst possible pain).	From reflection of mucoperiosteum till delivery of tooth out of socket.

Collaborators and Investigators

• Sponsor: Qassim University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2024
• Primary Completion (Estimated): May 2, 2026
• Study Completion (Estimated): May 2, 2026

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Articaine; Buccal infiltration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Carticaine
• Other Study ID Numbers: 608/45/14624

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: Study protocol will be provided only if requested through proper channel with proper justification.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

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