The Effectiveness of Buccal Infiltration Only Using Articaine for Extraction of Mandibular Molar

Phase 4

Not yet recruiting

• Conditions: Pain

• Registration Number: NCT06161714
• Lead Sponsor: Riyadh Elm University

Brief Summary

The goal of this clinical trial, is to test out the efficacy of using Articaine only as a local anesthesia as buccal infiltration to extract lower molar teeth.

Study will be performed in patients visiting Riyadh Elm University clinics seeking extraction of lower molars bilaterally, in each visit one molar tooth will be extracted using Ariticaine and the second visit with Lidocaine, pain level will be monitored and documented.

This study may be helpful in providing scientific information to the oral maxillofacial surgeons which will assist them in choosing the best local anesthetic agent, and possibly substituting using inferior alveolar nerve block with infiltration only when extracting the mandibular posterior teeth.

Detailed Description

This is a double-blind, randomized clinical trial, which will involve 40 patients visiting the out-patient department of Oral and Maxillofacial surgery. For each patient, one mandibular molar will be extracted from right as well as left side, with one side being anesthetized using 4% articaine with 1:100,000 epinephrine and other with 2% lidocaine with 1:100,000 epinephrine buccal infiltration only. Evaluation and comparison will be done on the basis of pain prevalence exhibited by the patients while extraction.

Study Timeline

• Study First Submitted: 2023-11-25
• Study Start: 2023-11-30
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-08
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-04-10
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Male and female patients
• Patients with age more than 18 years
• Patients indicated for at least one mandibular molar extraction
• Patients with the ability to fill the questionnaire

Exclusion Criteria

• Patients with abscess or any lesion, which may affect the local anesthesia provision.
• Patients with stage III mobile teeth
• Patients with a history of medical conditions such as diabetes mellitus, heart disease, pregnancy, allergy or renal disease
• Patients who are not able to give an informed consent or are not agreeing to take part in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pain measurement	Pain will be measured after injection, during extraction procedure and at the end of the session immediately after finishing the procedure, scale of pain will be 0 for no pain and 10 for maximum pain	Pain will be measured using the vial analogue scale