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

Not Applicable

Active, not recruiting

• Conditions: Anesthesia, Local
• Interventions: Procedure: Maxillary extraction without palatal injection; Procedure: Maxillary extraction with buccal and palatal injection

• Registration Number: NCT05951907
• Lead Sponsor: University of Baghdad

Brief Summary

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.

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 Timeline

• Study Start: 2022-01-05
• Primary Completion: 2022-12-10
• Status Verified: 2023-07
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-16
• Last Update Submitted: 2023-07-16
• Study First Posted: 2023-07-19
• Last Update Posted: 2023-07-19
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Maxillary extraction without palatal injection	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.
control group	Maxillary extraction with buccal and palatal injection	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.

Primary Outcome Measures

Name	Time	Method
Pain during Extraction	Assessment of pain in the period during which the extraction has been made and up to 5 minutes after extraction of the tooth.	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 .

Trial Locations

Locations (1)

Almustafa Qays; 🇮🇶 Baghdad, Almansour, Iraq