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Lower Third Molar Removal With 2% and 4% Articaine

Primary Purpose

Impacted Third Molar Tooth, Adverse Reaction to Other Local Anesthetics

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Surgery with 2%Articaine first, then Surgery with 4% Articaine
Surgery with 4%Articaine first, then Surgery with 2% Articaine
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Impacted Third Molar Tooth focused on measuring Articaine, Lower third molar, Oral Surgery

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

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

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

    Arm Description

    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)

    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)

    Outcomes

    Primary Outcome Measures

    Onset of Anesthetic
    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
    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
    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.
    Blood Pressure
    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.
    Heart Rate
    Heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
    Oxygen Saturation
    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

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

    Full Information

    First Posted
    May 18, 2015
    Last Updated
    October 30, 2020
    Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02457325
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Impacted Third Molar Tooth, Adverse Reaction to Other Local Anesthetics
    Keywords
    Articaine, Lower third molar, Oral Surgery

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Surgery With 2% Articaine first, then Surgery With 4%Articaine
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    Surgery With 4%Articaine first, then Surgery With 2% Articaine
    Arm Type
    Experimental
    Arm Description
    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)
    Intervention Type
    Drug
    Intervention Name(s)
    Surgery with 2%Articaine first, then Surgery with 4% Articaine
    Other Intervention Name(s)
    Lower third molar with 2% Articaine and 4% Articaine
    Intervention Description
    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)
    Intervention Type
    Drug
    Intervention Name(s)
    Surgery with 4%Articaine first, then Surgery with 2% Articaine
    Other Intervention Name(s)
    Lower third molar with 4% Articaine and 2% Articaine
    Intervention Description
    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 Measure Information:
    Title
    Onset of Anesthetic
    Description
    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.
    Time Frame
    During the surgical procedure, an average of 30 minutes
    Title
    Quality of Anesthesia
    Description
    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.
    Time Frame
    During the surgical procedure, an average of 30 minutes
    Title
    Intraoperative Bleeding
    Description
    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.
    Time Frame
    During the surgical procedure, an average of 30 minutes
    Title
    Blood Pressure
    Description
    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.
    Time Frame
    During the surgical procedure, an average of 30 minutes
    Title
    Heart Rate
    Description
    Heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
    Time Frame
    During the surgical procedure, an average of 30 minutes
    Title
    Oxygen Saturation
    Description
    Oxygen saturation to be verified and recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
    Time Frame
    During the surgical procedure, an average of 30 minutes
    Secondary Outcome Measure Information:
    Title
    Duration of Post-operative Analgesia
    Description
    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.
    Time Frame
    During the day of the surgery, 24 hours
    Title
    Postoperative Mouth Opening
    Description
    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.
    Time Frame
    Seventh postoperative days
    Title
    Wound Healing of the Operated Area
    Description
    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).
    Time Frame
    Seventh postoperative day
    Title
    Evaluation of Post-surgical Pain
    Description
    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.
    Time Frame
    Seventh postoperative day
    Title
    Postoperative Anesthesia
    Description
    Duration of postoperative anesthesia, represented by the lack of sensibility of the mucosa, tongue, and inferior lip.
    Time Frame
    During the day of the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlos F Santos, PhD
    Organizational Affiliation
    Bauru School of Dentistry/University of Sao Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data are presented as mean and standard deviation
    Citations:
    PubMed Identifier
    26202994
    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.
    Results Reference
    derived

    Learn more about this trial

    Lower Third Molar Removal With 2% and 4% Articaine

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