Lower Third Molar Removal With 2% and 4% Articaine

Phase 4

Completed

• Conditions: Impacted Third Molar Tooth; Adverse Reaction to Other Local Anesthetics
• Interventions: Drug: Surgery with 2%Articaine first, then Surgery with 4% Articaine; Drug: Surgery with 4%Articaine first, then Surgery with 2% Articaine

• Registration Number: NCT02457325
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Results First Submitted: 2015-12-01
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-30
• Last Update Submitted: 2020-10-30
• Results First Posted: 2020-11-24
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Need of lower third molar surgeries in similar positions

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Surgery With 2% Articaine first, then Surgery With 4%Articaine	Surgery with 2%Articaine first, then Surgery with 4% Articaine	First Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Surgery With 4%Articaine first, then Surgery With 2% Articaine	Surgery with 4%Articaine first, then Surgery with 2% Articaine	First Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)

Primary Outcome Measures

Name	Time	Method
Onset of Anesthetic	During the surgical procedure, an average of 30 minutes	Onset of anesthetic agent action, 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 Anesthesia	During the surgical procedure, an average of 30 minutes	Quality of anesthesia during surgery based on a category 3-point scale: 1) the patient reported no discomfort; 2) the patient reported discomfort, without the need to supplement the anesthesia; 3) reported some discomfort by the patient, requiring anesthesia complementation. Intraoral bleeding that will be evaluated by the surgeon according to a 3-point scale (1: minimal, 2: normal and 3: Maximum), immediately after the following steps: injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing.
Intraoperative Bleeding	During the surgical procedure, an average of 30 minutes	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, bone removal (when this procedure was necessary), tooth extraction, cleaning of the operated site, and completion of suturing.
Heart Rate	During the surgical procedure, an average of 30 minutes	Heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
Blood Pressure	During the surgical procedure, an average of 30 minutes	mean blood pressure was verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters.
Oxygen Saturation	During the surgical procedure, an average of 30 minutes	Oxygen saturation to be verified and recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.

Secondary Outcome Measures

Name	Time	Method
Duration of Post-operative Analgesia	During the day of the surgery, 24 hours	Duration of post-operative analgesia (in minutes) provided by the local anesthetic will be determined by the difference between the end time of the completion of suture and the one for the first intake piroxicam capsule for the relief of discomfort after surgery, the patient noted in token that you will be provided. Duration of post-surgical anesthesia (in minutes) on the soft tissues provided by local anesthetic, represented by the lack of sensitivity in the mucosa, tongue and lower lip after the surgery. The patient will note the time at which this phenomenon happens on the card which will be provided.
Postoperative Mouth Opening	Seventh postoperative days	Mouth opening (mm) between the mesial-incisal corners of the upper and lower right central incisors at maximum opening of the jaws was measured and recorded. Results presented below represent those assessed on the seventh postoperative day.
Wound Healing of the Operated Area	Seventh postoperative day	Quality of wound healing of the operated area classified by the surgeon according to a scale of three types of points: 1-normal healing, 2-delayed healing, 3-wound healing complicated by the presence of alveolitis at the time of removal of the suture (7th postoperative day).
Evaluation of Post-surgical Pain	Seventh postoperative day	Subjective evaluation of post-surgical pain, which was annotated by the volunteer, a Visual Analogue Scale (VAS, 0-100 mm - higher values represent a worse outcome) in the postoperative period.
Postoperative Anesthesia	During the day of the surgery	Duration of postoperative anesthesia, represented by the lack of sensibility of the mucosa, tongue, and inferior lip.