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

Sponsor
University of Baghdad (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05951907
Collaborator
(none)
200
1
2
19.8
10.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Maxillary extraction without palatal injection
  • Procedure: Maxillary extraction with buccal and palatal injection
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Case-ControlCase-Control
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
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.
Actual Study Start Date :
Jan 5, 2022
Actual Primary Completion Date :
Dec 10, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Almustafa Qays Baghdad Almansour Iraq 10013

Sponsors and Collaborators

  • University of Baghdad

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Almustafa Qays Abdulkareem, ALMUSTAFA QAYS ABDULKAREEM, POST GRADUATE STUDENT,UNIVERSITY F BAGHDAD, University of Baghdad
ClinicalTrials.gov Identifier:
NCT05951907
Other Study ID Numbers:
  • Extraction By Articaine
First Posted:
Jul 19, 2023
Last Update Posted:
Jul 19, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 19, 2023