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Lower third molar removal with 2% articaine.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2c236v
Enrollment
Unknown
Registered
2011-09-01
Start date
2011-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local anesthesia during lower third molar removals.

Interventions

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
drug
procedure/surgery

Sponsors

Faculdade de Odontologia de Bauru - Universidade de São Paulo
Lead Sponsor

Eligibility

Age
18 Years to 45 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Brazil

Contacts

Public ContactCarlos Santos

Faculdade de Odontologia de Bauru - Universidade de São Paulo

cebola@usp.br(14)32358276

Outcome results

None listed

Source: REBEC (via WHO ICTRP)