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NCT Number: NCT04645888

Articaine and Bupivacaine in Impacted 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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University Faculty of Dentistry

Kocaeli, Basiskele, 41190, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Impacted tooth surgery

Procedure

Surgical extraction of İmpacted tooth

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2020
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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