Clinical trial NCT06161714: The Effectiveness of Buccal Infiltration Only Using Articaine for Extraction of Mandibular Molar
Official title: The Effectiveness of Buccal Infiltration Only Using Articaine for Routine Exodontia of Mandibular Molar: A Cross-Over Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pain
Lead sponsor: Riyadh Elm University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: One 1.8 ml cartridge of 4% articaine with 1:100,000 epinephrine will be utilized in the articaine group and one 1.8 ml cartridge of 2% lidocaine with 1:100,000 epinephrine will be utilized in the lidocaine group. The cartridges will be of similar size and shape, to be allotted a special code, enclosed in thin, adhesive tape by the distributor, and kept into one box for articaine and another box for lidocaine.

A 27-gauge needle will be used for buccal infiltration in each case. Any sensation of pain after administering the local anesthesia will be considered as a failure and an inferior alveolar nerve block will be given. Otherwise, the tooth will be extracted with no additional anesthesia.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain measurement
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Albatool.a.baroom2021@student.riyadh.edu.sa
name: Albatool Baroom
role: PRINCIPAL_INVESTIGATOR
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