Buccal Infiltration of Different Volumes of Articaine for Extraction.

Not Applicable

Not yet recruiting

• Conditions: Buccal Infiltration; Articaine; Anesthesia
• Interventions: Other: 3.6 ml of 4% Articaine; Other: 1.8 ml of 4% Articaine

• Registration Number: NCT06630819
• Lead Sponsor: Qassim University

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.

Study Timeline

• Study First Submitted: 2024-09-24
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Study Start: 2024-11-03
• Primary Completion: 2025-11-02
• Study Completion: 2026-02-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	3.6 ml of 4% Articaine	Buccal infiltration of 3.6 ml of 4% Articaine
Group B	1.8 ml of 4% Articaine	Buccal infiltration of 1.8 ml of 4% Articaine

Primary Outcome Measures

Name	Time	Method
Intensity of pain	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	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	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).

Trial Locations

Locations (1)

Qassim University; 🇸🇦 Buraidah, Al qassim, Saudi Arabia