Lower third molar removal with 2% articaine.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-2c236v
• Date of registration: 01/09/2011
• Primary sponsor: Faculdade de Odontologia de Bauru - Universidade de São Paulo - Brazil
• Public title: Lower third molar removal with 2% articaine.
• Scientific title: Evaluation of the anesthetic efficacy and hemodynamic effects in the use of 2% and 4% articaine associated with 1:200,000 epinephrine in lower third molar removals.
• Date of first enrolment: 01/07/2011
• Target sample size: 50
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-2c236v/
• Study design: Clinical double-blind, randomizedcontrolled,; cross-over study.

Countries of recruitment

Brazil

Contacts

• Name: Carlos Santos
• Affiliation: Faculdade de Odontologia de Bauru - Universidade de São Paulo

• Name: Carlos Santos
• Affiliation: Faculdade de Odontologia de Bauru - Universidade de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: Precise indication of removal of the two
lower third molars in similar positions in the same volunteer, as observed on panoramic radiograph;
All patients will provide written informed
consent during the pretreatment screening period before any study procedures are performed. The patients will be randomly selected regarding gender. The minimum age for inclusion in the study will be 18 years old and the maximum 45 years old.
Exclusion criteria: Presence of systemic diseases;
Presence of local inflammation and/or
infection;
Any history of allergic reaction to local
anesthetics, gastrointestinal bleeding or
ulceration;
Cardiovascular and kidney diseases;
Asthma and allergy to aspirin, piroxicam or
any other non-steroidal antiinflammatory
drug;
Regular use of any non-steroidal
antiinflammatory drug, pregnancy or breast feeding.

Age minimum: 18Y
Age maximum: 45Y
Gender: -

Health Condition(s) or Problem(s) studied

Local anesthesia during lower third molar removals.
K10.9
K11.8

Intervention(s)

Group I: 50 patients, after randomization of the local anesthetic solution, will undergo unilateral lower third molar extraction with 2% or 4% articaine (with 1:200,000 epinephrine), in the dose of 54 mg or 108 mg, respectively (one and a half cartridge), in a double-blind manner.
Group II: One to two months after the first
extraction, the same 50 patients in Group I
will undergo extraction of the contralateral lower third molar with the local anesthetic not used in the first extraction, in the dose of 54 mg or 108 mg, respectively (one and a half cartridge), of 2% or 4% articaine (with 1:200,000 epinephrine).

Primary Outcome(s)

For each surgical procedure the following
parameters will be assessed:
Total volume of anesthetic solution used
during the surgery (in mL).
Onset of anesthetic agent action (latency,
in minutes), as determined by the loss of
sensibility of the inferior lip, the
corresponding half of the tongue, and the
mucosa as reported by the patient.
Quality of the anesthesia provided by the
local anesthetic during the surgery and
evaluated by the surgeon, according to a
modification of the method described by
Sisk (1986), based on a 3-point category
rating scale: 1) no discomfort reported by
the patient during the surgery; 2) any
discomfort reported by patient during the
surgery, without the need for additional
anesthesia; and 3) any discomfort reported
by patient during the surgery, with the need
of additional anesthesia.
Difficulty of the surgery according to the
surgical trauma, rated by the surgeon at the
completion of each extraction, according to
a 3-point category rating scale: 1: easy; 2:
normal; 3: complicated.
Duration of the surgery (in minutes),
corresponding to the period between the
first incision and the final suture.
Duration of postoperative analgesia (in
minutes), as determined by the difference
between the time at the end of the surgery
and that at ingestion of the first piroxicam
capsule for pain relief, recorded by the
patient in a specific chart that will be
provided.
Duration of postoperative anesthesia (in
minutes), represented by the lack of
sensibility of the mucosa, tongue, and
inferior lip after the surgery. Patients will
record the moment that the anesthetic had
worn off in a specific chart that will be
provided.
Intraoperative bleeding, rated by the
surgeon according to a 3-point category
rating scale (1: minimal bleeding; 2: normal
bleeding; 3: excessive bleeding) (Sisk,
1986), immediately after the following
steps: injection of the first cartridge of
articaine, tissue incision, flap reflection, osteotomy, tooth sectioning, extraction, cleaning of the surgical place and stitches.
Systolic, diastolic, and mean arterial
pressure; heart rate; and oxygen saturation,
measured before the surgery and
immediately after the steps described in
item 8. All of the measurements will be
automated and noninvasive, performed
with a device for monitoring hemodynamic
parameters (DX2010; Dixtal Biomédica Ind
e Com Ltda, Marília/SP, Brazil) according
to the manufacturer's instructions.

Secondary ID(s)

CAAE-0106.0.224.000-09

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo - Brazil