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

NCT05951907 | Unknown

• 1 other identifier: Extraction By Articaine
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

control group

ACTIVE COMPARATOR

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

study group

EXPERIMENTAL

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

Interventions

Maxillary extraction without palatal injection PROCEDURE

Extraction of maxillary premolars by only buccal injection without palatal by using articaine 4% HCL with epinephrine (1:100,000)

study group

Maxillary extraction with buccal and palatal injection PROCEDURE

Extraction of maxillary premolars by only buccal and palatal injection by using lidocaine 2 % HCL with epinephrine (1:80,000)

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Almustafa Qays

Baghdad, Almansour, 10013, Iraq

Location

Study Officials

• Hasanain A. Al-Jumaily, C.A.B.M.S

  College of Dentistry - University of Baghdad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ALMUSTAFA QAYS ABDULKAREEM, POST GRADUATE STUDENT,UNIVERSITY F BAGHDAD

Model Details: Case-Control

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 19, 2023
• Study Start: January 5, 2022
• Primary Completion: December 10, 2022
• Study Completion: September 1, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

IR (1)