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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05951907
Other study ID # Extraction By Articaine
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 5, 2022
Est. completion date September 2023

Study information

Verified date July 2023
Source University of Baghdad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date September 2023
Est. primary completion date December 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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)
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)

Locations

Country Name City State
Iraq Almustafa Qays Baghdad Almansour

Sponsors (1)

Lead Sponsor Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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