Clinical trial NCT02457325: Lower Third Molar Removal With 2% and 4% Articaine
Official title: Comparative Analysis Between 2% and Articaine Articaine 4%, Both With 1: 200,000 Epinephrine: Evaluation of Anesthetics Efficacy, Intraoperative Bleeding and Hemodynamic Parameters in Extraction of Lower Third Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impacted Third Molar Tooth
Adverse Reaction to Other Local Anesthetics
Keywords: Articaine
Lower third molar
Oral Surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The present clinical trial randomized compared the clinical efficacy of the local anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 2% or 4% (both with 1:200,000 adrenaline) in a double-blind, randomized and crossed manner.

Detailed description: The present clinical trial randomized compared the clinical efficacy of the local anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. This study evaluated the clinical efficacy of two concentrations (2% and 4%) of the local anesthetic articaine, a local anesthetic of moderate duration, associated with adrenalin at 1: 200,000 in 50 patients aged less than 18 years and in need of extraction of the two third molars with similar positions. Evaluated the following parameters: 1) onset of action of the anesthetic agent, 2) the total amount of anesthesia used during surgery, 3) onset and duration of surgery after the administration of the local anesthetic, 4) the incidence, type and severity of adverse reactions, 5) postoperative control of mouth opening, 6) subjective evaluation of postoperative pain, 7) postoperative duration of anesthesia, 8) Total amount of relief medication and 9) heart rate and systolic and diastolic blood pressure before during and after surgery. The comparative analysis of the data and the application of proper statistical tests provided the basis for an assessment of the efficiency of both concentrations of the local anesthetic articaine (2% and 4%) with adrenalin at 1: 200,000.

Eligibility criteria: Inclusion Criteria:

* Need of lower third molar surgeries in similar positions

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.

Primary outcomes:
measure: Onset of Anesthetic
timeFrame: During the surgical procedure, an average of 30 minutes
measure: Quality of Anesthesia
timeFrame: During the surgical procedure, an average of 30 minutes
measure: Intraoperative Bleeding
timeFrame: During the surgical procedure, an average of 30 minutes
measure: Blood Pressure
timeFrame: During the surgical procedure, an average of 30 minutes
measure: Heart Rate
timeFrame: During the surgical procedure, an average of 30 minutes
measure: Oxygen Saturation
timeFrame: During the surgical procedure, an average of 30 minutes
Secondary outcomes:
measure: Duration of Post-operative Analgesia
timeFrame: During the day of the surgery, 24 hours
measure: Postoperative Mouth Opening
timeFrame: Seventh postoperative days
measure: Wound Healing of the Operated Area
timeFrame: Seventh postoperative day
measure: Evaluation of Post-surgical Pain
timeFrame: Seventh postoperative day
measure: Postoperative Anesthesia
timeFrame: During the day of the surgery
Other outcomes:
Locations:
Study officials:
affiliation: Bauru School of Dentistry/University of Sao Paulo
name: Carlos F Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Senes AM, Calvo AM, Colombini-Ishikiriama BL, Goncalves PZ, Dionisio TJ, Sant'ana E, Brozoski DT, Lauris JR, Faria FA, Santos CF. Efficacy and Safety of 2% and 4% Articaine for Lower Third Molar Surgery. J Dent Res. 2015 Sep;94(9 Suppl):166S-73S. doi: 10.1177/0022034515596313. Epub 2015 Jul 22.