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NCT Number: NCT02457325

Lower Third Molar Removal With 2% and 4% Articaine

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.

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Key information

Conditions

Impacted Third Molar Tooth Adverse Reaction to Other Local Anesthetics

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery with 2%Articaine first, then Surgery with 4% Articaine

Drug

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)

Other names: Lower third molar with 2% Articaine and 4% Articaine

Surgery with 4%Articaine first, then Surgery with 2% Articaine

Drug

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)

Other names: Lower third molar with 4% Articaine and 2% Articaine

Primary outcomes

  1. Onset of Anesthetic

    Time frame: 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.

  2. Quality of Anesthesia

    Time frame: 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.

  3. Intraoperative Bleeding

    Time frame: 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.

  4. Blood Pressure

    Time frame: 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.

  5. Heart Rate

    Time frame: 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.

  6. Oxygen Saturation

    Time frame: 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 outcomes

  1. Duration of Post-operative Analgesia

    Time frame: 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.

  2. Postoperative Mouth Opening

    Time frame: 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.

  3. Wound Healing of the Operated Area

    Time frame: 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).

  4. Evaluation of Post-surgical Pain

    Time frame: 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.

  5. Postoperative Anesthesia

    Time frame: During the day of the surgery

    Duration of postoperative anesthesia, represented by the lack of sensibility of the mucosa, tongue, and inferior lip.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 29, 2015
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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