Lower Third Molar Removal With 2% and 4% Articaine

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02457325

Enrollment

Registered

2015-05-29

Start date

2011-06-30

Completion date

2012-12-31

Last updated

2020-11-24

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

Conditions

Adverse Reaction to Other Local Anesthetics, Impacted Third Molar Tooth

Keywords

Articaine, Lower third molar, Oral Surgery

Brief summary

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.

Interventions

DRUGSurgery 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)

DRUGSurgery 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)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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.

Secondary

Measure	Time frame	Description
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.
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.

Participant flow

Recruitment details

50 patients were recruited to perform bilateral surgery for extraction of lower third molars, at the Faculty of Dentistry of Bauru

Pre-assignment details

46 of 50 patients were randomized. Of those not randomized, 4 did not return to folow up and were excluded of the study.

Participants by arm

Arm	Count
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)	23
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)	23
Total	46

Withdrawals & dropouts

Period	Reason	FG000	FG001
First Intervention (1 Day)	Lost to Follow-up	2	2

Baseline characteristics

Characteristic	Surgery With 4%Articaine First, Then Surgery With 2%Articaine	Surgery With 2%Articaine First, Then Surgery With 4% Articaine	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	23 Participants	23 Participants	46 Participants
Age, Continuous	23 years	23 years	23 years
Region of Enrollment Brazil	23 participants	23 participants	46 participants
Sex: Female, Male Female	9 Participants	9 Participants	18 Participants
Sex: Female, Male Male	14 Participants	14 Participants	28 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	1 / 46	1 / 46
serious Total, serious adverse events	0 / 46	0 / 46

Outcome results

Primary

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.