Articaine and Bupivacaine in Impacted Tooth Surgery

• ClinicalTrials.gov Identifier: NCT04645888
• Recruitment Status: Completed
• First Posted: November 27, 2020
• Last Update Posted: November 27, 2020
• Sponsor: Kocaeli University
• Information provided by (Responsible Party): Fatih Mehmet Coskunses, Kocaeli University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Impacted Third Molar Tooth	Procedure: Impacted tooth surgery	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized, split-mouth, triple-blinded study was designed.
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Screening
• Official Title: Evaluation of the Effects of Articaine and Bupivacaine in Impacted Third Molar Tooth Surgery
• Actual Study Start Date: December 1, 2018
• Actual Primary Completion Date: February 25, 2019
• Actual Study Completion Date: February 25, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Hemodynamic Changes [ Time Frame: 60 minutes ]
   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).
2. Postoperative pain [ Time Frame: 1 week ]
   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.

Secondary Outcome Measures :

1. Maximum mouth opening [ Time Frame: 7days ]
   Maximal incisal opening (MIO) measured with ruler preoperatively and at the 7th day.
2. Duration of Surgery [ Time Frame: 60 minutes ]
   Duration of the surgery, which was determined by the time between the first incision to last suture was recorded.
3. Onset of anesthetic action [ Time Frame: 10 minutes ]
   Onset of anesthetic action was be determined by the first sign of numbness of the ipsilateral lower lip, tongue and alveolar mucosa,
4. Operation time [ Time Frame: 60 minutes ]
   The time between the first incision and the last suture was evaluated as operation time.
5. Quality of the anesthesia [ Time Frame: 60 minutes ]
   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.
6. Intraoperative bleeding [ Time Frame: 60 minutes ]
   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.
7. Surgical difficulty [ Time Frame: 60 minutes ]

   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).

8. Duration of the postoperative anesthesia [ Time Frame: 6 hours ]
   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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Turkey

Kocaeli University Faculty of Dentistry

Kocaeli, Basiskele, Turkey, 41190

Sponsors and Collaborators

Kocaeli University

Investigators

• Principal Investigator: Berkay Tokuc, DDS; Kocaeli University

More Information

• Responsible Party: Fatih Mehmet Coskunses, Associate Proffesor, Kocaeli University
• ClinicalTrials.gov Identifier: NCT04645888
• Other Study ID Numbers: 1
• First Posted: November 27, 2020
• Last Update Posted: November 27, 2020
• Last Verified: November 2020

• 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

Additional relevant MeSH terms:

Tooth, Impacted; Tooth Diseases; Stomatognathic Diseases