Impacted Third Molar Tooth
Conditions
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.
Interventions
PROCEDUREImpacted tooth surgery
Surgical extraction of İmpacted tooth
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
Randomized, split-mouth, triple-blinded study was designed.
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Changes | 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). |
| Postoperative pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Onset of anesthetic action | 10 minutes | Onset of anesthetic action was be determined by the first sign of numbness of the ipsilateral lower lip, tongue and alveolar mucosa, |
| Operation time | 60 minutes | The time between the first incision and the last suture was evaluated as operation time. |
| Quality of the anesthesia | 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. |
| Maximum mouth opening | 7days | Maximal incisal opening (MIO) measured with ruler preoperatively and at the 7th day. |
| Surgical difficulty | 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). |
| Duration of the postoperative anesthesia | 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. |
| Intraoperative bleeding | 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. |
| Duration of Surgery | 60 minutes | Duration of the surgery, which was determined by the time between the first incision to last suture was recorded. |
Countries
Turkey (Türkiye)
Outcome results
None listed