Articaine and Bupivacaine in Impacted Tooth Surgery

NCT04645888 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Maximum mouth opening

  7days

• Duration of Surgery

  60 minutes

• Onset of anesthetic action

  10 minutes

• Operation time

  60 minutes

• Quality of the anesthesia

  60 minutes

Study Arms (2)

Articaine

ACTIVE COMPARATOR

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

Bupivacaine

ACTIVE COMPARATOR

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

Interventions

Impacted tooth surgery PROCEDURE

Surgical extraction of İmpacted tooth

Articaine; Bupivacaine

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Faculty of Dentistry

Kocaeli, Basiskele, 41190, Turkey (Türkiye)

Location

Study Officials

• Berkay Tokuc, DDS

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This was a triple-blinded study in which the surgeon, the patient and the statistician who performed the data analysis did not know which anesthetic solution had been used.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffesor

Model Details: Randomized, split-mouth, triple-blinded study was designed.

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: December 1, 2018
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

TU (1)