The Anesthetic Efficacy of Lidocaine and Articaine as Buccal Injection for Maxillary Premolar Teeth Extraction.

The Anesthetic Efficacy of Articaine as Buccal Injection Compared to Lidocaine Baccual and Palatal Injection for Maxillary Premolar Teeth Extraction A Randomized, Single-Blinded, Clinical Trial.

This study Is designed as a prospective randomized, single-blinded clinical trial. To evaluate The anesthetic efficacy of articaine as a buccal Injection for maxillary premolar teeth extraction, compared to lidocaine as a buccal and palatal injection.

Study Overview

• Status: Active, not recruiting
• Conditions: Anesthesia, Local
• Intervention / Treatment: Procedure: Maxillary extraction with buccal and palatal injection; Procedure: Maxillary extraction without palatal injection

Detailed Description

In the current study, the sample size (200) patients were distributed into two groups, group (A), 100 patients extracted upper premolar teeth by using 1.8 mL cartridges of 4% articaine hydrochloride with 1:100,000 epinephrine (Artheek, Colombia) as a buccal injection without palatal injection, and Group (B), 100 patients were removed upper premolar teeth by using Injectable local anesthetic agents included; 1.8 mL cartridges of 2% lidocaine hydrochloride with 1:80,000 epinephrine (Huons, Korea) as a buccal and palatal injection, the pain assessment after extraction was assessed by using (vas) visual analog scale, comparison between the outcomes by the two groups were evaluated, according to many variables (age, gender, extracted tooth, type of anesthesia, extraction duration).

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Almansour
    • Baghdad, Almansour, Iraq, 10013
      • Almustafa Qays

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients ≥ 16 years old, including both genders.
2. Patients indicated for extraction of one of the maxillary premolar's teeth.

Exclusion Criteria:

1. Patients who were allergic to the local anesthetic agents used in this study.
2. Patients who presented with acute periapical infections.
3. Patients who required surgical extraction that entails flap reflection and bone removal.
4. Pregnant patients.
5. Patients with uncontrolled systemic diseases.
6. Patients are taking medications affecting pain assessment, like opioids.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; A control group in which the extraction of the maxillary premolar's teeth was carried out under buccal and palatal infiltration anesthesia with 1.8 mL 2% lidocaine hydrochloride with 1:80,000 epinephrine.	Procedure: Maxillary extraction with buccal and palatal injection; Extraction of maxillary premolars by only buccal and palatal injection by using lidocaine 2 % HCL with epinephrine (1:80,000)
Experimental: study group; A study group in which the extraction of the maxillary premolar's teeth proceeded under buccal without palatal infiltration anesthesia with 1.8 mL, 4% articaine hydrochloride with 1:100,000 epinephrine.	Procedure: Maxillary extraction without palatal injection; Extraction of maxillary premolars by only buccal injection without palatal by using articaine 4% HCL with epinephrine (1:100,000)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during Extraction	In the current study the pain during extraction was assessed by using the Visual Analogue Scale (VAS 0-10 cm ) one of the most commonly used self-reporting measures of pain, it measures a characteristic that is believed to range across a continuum of values range from (0 no pain) to the end (10 un bearable pain) which is not easy to measure directly .	Assessment of pain in the period during which the extraction has been made and up to 5 minutes after extraction of the tooth.

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Study Director: Hasanain A. Al-Jumaily, C.A.B.M.S, College of Dentistry - University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): December 10, 2022
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 16, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 16, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Extraction By Articaine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No