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Clinical Trials/NCT06630819
NCT06630819
Recruiting
Not Applicable

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

Qassim University2 sites in 1 country114 target enrollmentNovember 24, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Buccal Infiltration
Sponsor
Qassim University
Enrollment
114
Locations
2
Primary Endpoint
Intensity of pain
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 24, 2024
End Date
May 2, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Muhammad Atif Saleem Agwan

Assistant Professor

Qassim University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Intensity of pain

Time Frame: From reflection of mucoperiosteum till delivery of tooth out of socket.

VAS scale is a validated scale measuring pain with possible score range from 0 (no pain) to 100 (severe pain).

Time of onset of anesthesia

Time Frame: upto 10 minutes

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.

Presence or absence of pain

Time Frame: From reflection of mucoperiosteum till delivery of tooth out of socket.

A 100 mm Numerical rating scale assessing intraoperative pain. Possible score ranges from 0 (no pain) to 100 (worst possible pain).

Study Sites (2)

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