Articaine and Bupivacaine in Impacted Tooth Surgery

Evaluation of the Effects of Articaine and Bupivacaine in Impacted Third Molar Tooth Surgery

Articaine is a common local anesthetic used in oral surgery and belongs to the amide group of it has fast onset with little side effects. Bupivacaine is preferred in prolonged surgical procedures with its long duration of action and residual analgesic effect.

The aim of this study was to evaluate the anesthetic, analgesic, hemodynamic effects of 4% articaine and 0.5% bupivacaine in extraction of impacted mandibular third molar teeth in intraoperative and postoperative periods. Hemodynamic parameters, onset of anesthetic action, total amount, intraoperative comfort, intraoperative bleeding, duration of postoperative anesthesia and analgesia, rescue analgesic use, maximum incisal opening and postoperative pain at 6th, 12th, 24th, 48th and 72th hours and 7th day using a visual analogue scale be evaluated.

Study Overview

• Status: Completed
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Procedure: Impacted tooth surgery

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Basiskele
    • Kocaeli, Basiskele, Turkey, 41190
      • Kocaeli University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients above 18 years of age with bilaterally symmetric, impacted or partially impacted mandibular third molar and patients classified in American Society of Anesthesiologists (ASA) 1 group.

Exclusion Criteria:

• Patients with the presence of any systemic diseases, patients allergic to articaine and bupivacaine or any other NSAIDs and patients with analgesic or anti-inflammatory drugs usage in 15 days before to the surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Articaine; All surgeries were performed by the same surgeon and monitored by the same person. 4 % articaine with 1:200.000 epinephrine was administered to the patients in regional block of the inferior alveolar nerve technique at the first surgery. At the second intervention, patients received the other anesthetic solution which was not used at the first intervention. 1.5 cc of the solution was used to anesthetize the inferior alveolar and lingual nerve and the remaining 0.5 cc was infiltrated to anesthetize the buccal nerve.	Procedure: Impacted tooth surgery; Surgical extraction of İmpacted tooth
Active Comparator: Bupivacaine; All surgeries were performed by the same surgeon and monitored by the same person. % 0.5 bupivacaine without epinephrine was administered to the patients in regional block of the inferior alveolar nerve technique at the first surgery. At the second intervention, patients received the other anesthetic solution which was not used at the first intervention. 1.5 cc of the solution was used to anesthetize the inferior alveolar and lingual nerve and the remaining 0.5 cc was infiltrated to anesthetize the buccal nerve.	Procedure: Impacted tooth surgery; Surgical extraction of İmpacted tooth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic Changes	Systolic and diastolic blood pressure, cardiac rate and blood oxygen saturation level were monitored using a patient monitor before beginning of the surgery (T1), 1 min later following the anesthesia (T2) and immediately after the surgery (T3).	60 minutes
Postoperative pain	Postoperative pain was evaluated by Visual Analogue Scale (VAS) ranging from 0 to 10 and patients were instructed to complete the scale in 6th, 12th, 24th, 48th and 72th hours and 7th day postoperatively.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum mouth opening	Maximal incisal opening (MIO) measured with ruler preoperatively and at the 7th day.	7days
Duration of Surgery	Duration of the surgery, which was determined by the time between the first incision to last suture was recorded.	60 minutes
Onset of anesthetic action	Onset of anesthetic action was be determined by the first sign of numbness of the ipsilateral lower lip, tongue and alveolar mucosa,	10 minutes
Operation time	The time between the first incision and the last suture was evaluated as operation time.	60 minutes
Quality of the anesthesia	The quality of the anesthesia was evaluated by the surgeon which was based on a 3- point category rating scale: Grade 1: no discomfort reported by the patient during the surgery; Grade 2: any discomfort reported by patient during the surgery, without the need of additional anesthesia; Grade 3: any discomfort reported by patient during the surgery, with the need of additional anesthesia.	60 minutes
Intraoperative bleeding	Intraoperative bleeding was rated by the surgeon which based on a 3-point category rating scale as: Grade 1: minimal bleeding; Grade 2: normal bleeding; Grade 3: excessive bleeding.	60 minutes
Surgical difficulty	Surgical difficulty was determined by modified Parant scale as follows: Grade 1: extraction with forceps only; Grade 2: extraction by osteotomy; Grade 3: extraction by osteotomy and coronal section; Grade 4: complex procedures (root section).	60 minutes
Duration of the postoperative anesthesia	Duration of the postoperative anesthesia be determined by the absence of sensibility of ipsilateral lower lip, tongue and alveolar mucosa and duration of the postoperative analgesia determined by the time from the end of the operation to the first naproxen sodium intake.	6 hours

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Berkay Tokuc, DDS, Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): February 25, 2019
• Study Completion (Actual): February 25, 2019

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 21, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 21, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No