Trial Outcomes & Findings for Lower Third Molar Removal With 2% and 4% Articaine (NCT NCT02457325)

NCT ID: NCT02457325

Last Updated: 2020-11-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: During the surgical procedure, an average of 30 minutes
• Results posted on: 2020-11-24

Participant Flow

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

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

Participant milestones

Measure	Surgery With 2% Articaine First, Then 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 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)
First Intervention (1 Day) STARTED	25	25
First Intervention (1 Day) COMPLETED	23	23
First Intervention (1 Day) NOT COMPLETED	2	2
Washout (1-2 Months) STARTED	23	23
Washout (1-2 Months) COMPLETED	23	23
Washout (1-2 Months) NOT COMPLETED	0	0
Second Intervention (1 Day) STARTED	23	23
Second Intervention (1 Day) COMPLETED	23	23
Second Intervention (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Surgery With 2% Articaine First, Then 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 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)
First Intervention (1 Day) Lost to Follow-up	2	2

Baseline Characteristics

Lower Third Molar Removal With 2% and 4% Articaine

Baseline characteristics by cohort

Measure	Surgery With 2%Articaine First, Then Surgery With 4% Articaine n=23 Participants 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 n=23 Participants 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)	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	23 years n=5 Participants	23 years n=7 Participants	23 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment Brazil	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Surgery With 2%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Onset of Anesthetic	1.5 minutes Standard Deviation 0.6	1.5 minutes Standard Deviation 0.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Surgery With 2%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Quality of Anesthesia	1.8 units on a scale Standard Deviation 1.0	1.8 units on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Surgery With 2%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Intraoperative Bleeding	1.1 units on a scale Standard Deviation 0.1	1.1 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Surgery With 2%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Blood Pressure	119 mmHg Standard Deviation 11	123 mmHg Standard Deviation 11

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Surgery With 2%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Heart Rate	73 bpm Standard Deviation 17	73 bpm Standard Deviation 17

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Surgery With 2%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Oxygen Saturation	99 percentage of oxigen in blood Standard Deviation 4	99 percentage of oxigen in blood Standard Deviation 1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Surgery With 2%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Duration of Post-operative Analgesia	133 minutes Standard Deviation 110	125 minutes Standard Deviation 102

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Surgery With 2%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Postoperative Mouth Opening	36 mm Standard Deviation 10	35 mm Standard Deviation 11

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Surgery With 2%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Wound Healing of the Operated Area	1.2 units on a scale Standard Deviation 0.4	1.4 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Surgery With 2%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Evaluation of Post-surgical Pain	26 units on a scale Standard Deviation 29	26 units on a scale Standard Deviation 29

SECONDARY outcome

Timeframe: During the day of the surgery

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

Outcome measures

Measure	Surgery With 2%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 Participants Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Postoperative Anesthesia	187 minutes Standard Deviation 90	215 minutes Standard Deviation 77

Adverse Events

Surgery With 2%Articaine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Surgery With 4%Articaine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Surgery With 2%Articaine n=46 participants at risk Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)	Surgery With 4%Articaine n=46 participants at risk Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
Injury, poisoning and procedural complications paresthesia of the lingual nerve	2.2% 1/46 • Number of events 1 • 1 month after surgery	2.2% 1/46 • Number of events 1 • 1 month after surgery

Additional Information

Carlos Ferreira Santos

University of Sao Paulo / Bauru School of Dentistry

Phone: +551432358200

Email: cfsantos@fob.usp.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place