Articaine and Bupivacaine in Impacted Tooth Surgery

Impacted Third Molar Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645888
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: February 25, 2019

Study information

• Verified date: November 2020
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 25, 2019
• Est. primary completion date: February 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

Procedure:
• Impacted tooth surgery
Surgical extraction of Impacted tooth

Locations

Country	Name	City	State
Turkey	Kocaeli University Faculty of Dentistry	Kocaeli	Basiskele

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Maximum mouth opening	Maximal incisal opening (MIO) measured with ruler preoperatively and at the 7th day.	7days
Secondary	Duration of Surgery	Duration of the surgery, which was determined by the time between the first incision to last suture was recorded.	60 minutes
Secondary	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
Secondary	Operation time	The time between the first incision and the last suture was evaluated as operation time.	60 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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