Trial Outcomes & Findings for Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2 (NCT NCT02371759)

NCT ID: NCT02371759

Last Updated: 2017-05-03

Results Overview

Time until cessation in soft tissue numbness

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

256 participants

Primary outcome timeframe

Up to 6 hours after local anesthesia injection

Results posted on

2017-05-03

Participant Flow

Participants recruited between june 2013 and december 2015 among the patients of Clinic of Oral Surgery, Faculty of Dental Medicine, University of Belgrade

Participant milestones

Participant milestones
Measure
Diabetics: L+C Maxillary Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Overall Study
STARTED
32
31
33
31
27
26
25
28
Overall Study
COMPLETED
29
30
32
31
24
25
25
24
Overall Study
NOT COMPLETED
3
1
1
0
3
1
0
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Diabetics: L+C Maxillary Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Overall Study
Protocol Violation
3
1
1
0
3
1
0
3
Overall Study
Withdrawal by Subject
0
0
0
0
0
0
0
1

Baseline Characteristics

Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Total
n=220 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
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
Age, Categorical
Between 18 and 65 years
29 Participants
n=5 Participants
30 Participants
n=7 Participants
32 Participants
n=5 Participants
31 Participants
n=4 Participants
24 Participants
n=21 Participants
25 Participants
n=10 Participants
25 Participants
n=115 Participants
24 Participants
n=6 Participants
220 Participants
n=6 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
16 Participants
n=7 Participants
21 Participants
n=5 Participants
14 Participants
n=4 Participants
9 Participants
n=21 Participants
15 Participants
n=10 Participants
15 Participants
n=115 Participants
14 Participants
n=6 Participants
126 Participants
n=6 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
14 Participants
n=7 Participants
11 Participants
n=5 Participants
17 Participants
n=4 Participants
15 Participants
n=21 Participants
10 Participants
n=10 Participants
10 Participants
n=115 Participants
10 Participants
n=6 Participants
94 Participants
n=6 Participants
Region of Enrollment
Serbia
32 participants
n=5 Participants
31 participants
n=7 Participants
33 participants
n=5 Participants
31 participants
n=4 Participants
24 participants
n=21 Participants
25 participants
n=10 Participants
25 participants
n=115 Participants
24 participants
n=6 Participants
220 participants
n=6 Participants
Body Mass
78.72 kilograms
STANDARD_DEVIATION 11.19 • n=5 Participants
75.03 kilograms
STANDARD_DEVIATION 11.53 • n=7 Participants
85.84 kilograms
STANDARD_DEVIATION 14.76 • n=5 Participants
79.45 kilograms
STANDARD_DEVIATION 17.34 • n=4 Participants
79.50 kilograms
STANDARD_DEVIATION 15.22 • n=21 Participants
74.59 kilograms
STANDARD_DEVIATION 9.64 • n=10 Participants
71.01 kilograms
STANDARD_DEVIATION 12.08 • n=115 Participants
71.59 kilograms
STANDARD_DEVIATION 7.81 • n=6 Participants
76.90 kilograms
STANDARD_DEVIATION 8.42 • n=6 Participants
Fasting Plasma Glucose
8.12 milimoles per liter
STANDARD_DEVIATION 3.01 • n=5 Participants
7.55 milimoles per liter
STANDARD_DEVIATION 2.53 • n=7 Participants
9.66 milimoles per liter
STANDARD_DEVIATION 4.02 • n=5 Participants
8.35 milimoles per liter
STANDARD_DEVIATION 2.49 • n=4 Participants
NA milimoles per liter
STANDARD_DEVIATION NA • n=21 Participants
NA milimoles per liter
STANDARD_DEVIATION NA • n=10 Participants
NA milimoles per liter
STANDARD_DEVIATION NA • n=115 Participants
NA milimoles per liter
STANDARD_DEVIATION NA • n=6 Participants
NA milimoles per liter
STANDARD_DEVIATION NA • n=6 Participants
Duration of Diabetes
6.83 years
STANDARD_DEVIATION 4.59 • n=5 Participants
9.57 years
STANDARD_DEVIATION 5.51 • n=7 Participants
9.77 years
STANDARD_DEVIATION 7.62 • n=5 Participants
9.27 years
STANDARD_DEVIATION 6.09 • n=4 Participants
NA years
STANDARD_DEVIATION NA • n=21 Participants
NA years
STANDARD_DEVIATION NA • n=10 Participants
NA years
STANDARD_DEVIATION NA • n=115 Participants
NA years
STANDARD_DEVIATION NA • n=6 Participants
NA years
STANDARD_DEVIATION NA • n=6 Participants
Glycosilated Hemoglobin
7.42 percents
STANDARD_DEVIATION 1.25 • n=5 Participants
7.55 percents
STANDARD_DEVIATION 2.53 • n=7 Participants
7.63 percents
STANDARD_DEVIATION 1.72 • n=5 Participants
7.97 percents
STANDARD_DEVIATION 1.50 • n=4 Participants
NA percents
STANDARD_DEVIATION NA • n=21 Participants
NA percents
STANDARD_DEVIATION NA • n=10 Participants
NA percents
STANDARD_DEVIATION NA • n=115 Participants
NA percents
STANDARD_DEVIATION NA • n=6 Participants
NA percents
STANDARD_DEVIATION NA • n=6 Participants
Number of participants with modified diet
22 Participants
n=5 Participants
30 Participants
n=7 Participants
31 Participants
n=5 Participants
30 Participants
n=4 Participants
NA Participants
n=21 Participants
NA Participants
n=10 Participants
NA Participants
n=115 Participants
NA Participants
n=6 Participants
NA Participants
n=6 Participants
Number of participants on OHA therapy
28 Participants
n=5 Participants
29 Participants
n=7 Participants
30 Participants
n=5 Participants
30 Participants
n=4 Participants
NA Participants
n=21 Participants
NA Participants
n=10 Participants
NA Participants
n=115 Participants
NA Participants
n=6 Participants
NA Participants
n=6 Participants
Number of participants on insulin therapy
2 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
4 Participants
n=4 Participants
NA Participants
n=21 Participants
NA Participants
n=10 Participants
NA Participants
n=115 Participants
NA Participants
n=6 Participants
NA Participants
n=6 Participants
Hypertension
16 Participants
n=5 Participants
26 Participants
n=7 Participants
19 Participants
n=5 Participants
17 Participants
n=4 Participants
NA Participants
n=21 Participants
NA Participants
n=10 Participants
NA Participants
n=115 Participants
NA Participants
n=6 Participants
NA Participants
n=6 Participants
Coronary Artery Disease
12 Participants
n=5 Participants
14 Participants
n=7 Participants
14 Participants
n=5 Participants
13 Participants
n=4 Participants
NA Participants
n=21 Participants
NA Participants
n=10 Participants
NA Participants
n=115 Participants
NA Participants
n=6 Participants
NA Participants
n=6 Participants
Peripheral Neuropathy
9 Participants
n=5 Participants
12 Participants
n=7 Participants
12 Participants
n=5 Participants
10 Participants
n=4 Participants
NA Participants
n=21 Participants
NA Participants
n=10 Participants
NA Participants
n=115 Participants
NA Participants
n=6 Participants
NA Participants
n=6 Participants
Intraoral Neuropathy
14 Participants
n=5 Participants
16 Participants
n=7 Participants
17 Participants
n=5 Participants
18 Participants
n=4 Participants
NA Participants
n=21 Participants
NA Participants
n=10 Participants
NA Participants
n=115 Participants
NA Participants
n=6 Participants
NA Participants
n=6 Participants

PRIMARY outcome

Timeframe: Up to 6 hours after local anesthesia injection

Time until cessation in soft tissue numbness

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Duration of Intraoral Local Anesthesia
132.48 minutes
Standard Deviation 91.86
173.27 minutes
Standard Deviation 70.44
182.09 minutes
Standard Deviation 57.86
195.35 minutes
Standard Deviation 68.99
108.82 minutes
Standard Deviation 27.76
155.59 minutes
Standard Deviation 60.75
114.74 minutes
Standard Deviation 39.72
172.91 minutes
Standard Deviation 68.93

PRIMARY outcome

Timeframe: Up to 10 minutes after local anesthesia injection

Number of participants who reported values \> 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words "no pain" , while the other end is marked with 100 and words "the worst pain imanginable". VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to "no pain", and 10 corresponds to "the worst pain imaginable". For both scales, higher scores represent worse outcomes.

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Intensity of Intraoral Local Anesthesia
2 Participants
2 Participants
1 Participants
8 Participants
2 Participants
1 Participants
4 Participants
6 Participants

PRIMARY outcome

Timeframe: Baseline, 0 minutes

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Baseline Systolic Blood Pressure
135.2759 milimeters of Hg
Standard Deviation 16.69665611
137.7333 milimeters of Hg
Standard Deviation 18.43335308
134.8125 milimeters of Hg
Standard Deviation 18.66934265
134.4667 milimeters of Hg
Standard Deviation 17.69119729
124.0455 milimeters of Hg
Standard Deviation 11.07325079
128.1818 milimeters of Hg
Standard Deviation 15.49388931
125 milimeters of Hg
Standard Deviation 11.11918898
126.5909 milimeters of Hg
Standard Deviation 18.82322642

PRIMARY outcome

Timeframe: 10th minute

Systolic blood pressure values 5 minutes after local anesthesia injection

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Systolic Blood Pressure at 10 Minutes
130.3793 milimeters of Hg
Standard Deviation 18.81377496
136.8333 milimeters of Hg
Standard Deviation 14.27098173
137.4375 milimeters of Hg
Standard Deviation 19.73033934
132.6 milimeters of Hg
Standard Deviation 20.45858857
120.8182 milimeters of Hg
Standard Deviation 13.58092627
122.5909 milimeters of Hg
Standard Deviation 14.59503859
125.8261 milimeters of Hg
Standard Deviation 13.75979708
125,4091 milimeters of Hg
Standard Deviation 12.71541656

PRIMARY outcome

Timeframe: 15th minute

Systolic blood pressure values 10 minutes after local anesthesia injection

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Systolic Blood Pressure at 15 Minutes
133.5862 milimeters of Hg
Standard Deviation 13.51590925
133.4667 milimeters of Hg
Standard Deviation 14.12684735
137.4688 milimeters of Hg
Standard Deviation 19.28058421
132.0667 milimeters of Hg
Standard Deviation 17.89580957
114.4545 milimeters of Hg
Standard Deviation 11.89128241
116.9091 milimeters of Hg
Standard Deviation 12.78730431
123.8696 milimeters of Hg
Standard Deviation 13.61250878
127.1818 milimeters of Hg
Standard Deviation 18.58733917

PRIMARY outcome

Timeframe: 20th minute

Systolic blood pressure values 15 minutes after local anesthesia injection

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Systolic Blood Pressure at 20 Minutes
130.2414 milimeters of Hg
Standard Deviation 14.98011819
131.3333 milimeters of Hg
Standard Deviation 14.73755076
132.4063 milimeters of Hg
Standard Deviation 17.69428443
133.2333 milimeters of Hg
Standard Deviation 18.46560212
108.8182 milimeters of Hg
Standard Deviation 9.529630256
120.8636 milimeters of Hg
Standard Deviation 12.995587
123.8696 milimeters of Hg
Standard Deviation 12.15918788
124.6818 milimeters of Hg
Standard Deviation 19.56767588

PRIMARY outcome

Timeframe: 35th minute

Systolic blood pressure values 30 minutes after local anesthesia injection

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Systolic Blood Pressure at 35 Minutes
127.2759 milimeters of Hg
Standard Deviation 12.91979807
130.3 milimeters of Hg
Standard Deviation 13.12841089
132.5625 milimeters of Hg
Standard Deviation 17.0330561
132.7 milimeters of Hg
Standard Deviation 16.38723706
116.3636 milimeters of Hg
Standard Deviation 7.364945637
120.1364 milimeters of Hg
Standard Deviation 14.54809906
120.6522 milimeters of Hg
Standard Deviation 10.01185069
126.4545 milimeters of Hg
Standard Deviation 17.25916533

PRIMARY outcome

Timeframe: baseline, 0 minutes

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Baseline Diastolic Blood Pressure
74.1379 milimeters of Hg
Standard Deviation 11.37894088
81.7667 milimeters of Hg
Standard Deviation 9.722648048
75.25 milimeters of Hg
Standard Deviation 12.09372004
79.2 milimeters of Hg
Standard Deviation 15.61345574
73.1364 milimeters of Hg
Standard Deviation 9.627814144
80.9545 milimeters of Hg
Standard Deviation 11.23547644
76.3913 milimeters of Hg
Standard Deviation 5.694807287
75.0909 milimeters of Hg
Standard Deviation 12.72758194

PRIMARY outcome

Timeframe: 10th minute

Diastolic blood pressure values 5 minutes after local anesthesia injection

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diastolic Blood Pressure at 10 Minutes
74.0345 milimeters of Hg
Standard Deviation 8.398480979
75.3667 milimeters of Hg
Standard Deviation 12.09830424
75.6875 milimeters of Hg
Standard Deviation 14.74829132
79.1 milimeters of Hg
Standard Deviation 15.23497999
69.7273 milimeters of Hg
Standard Deviation 10.49798991
75.0909 milimeters of Hg
Standard Deviation 6.560408603
75.8261 milimeters of Hg
Standard Deviation 7.010720193
73.8636 milimeters of Hg
Standard Deviation 10.14793178

PRIMARY outcome

Timeframe: 15th minute

Diastolic blood pressure values 10 minutes after local anesthesia injection

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diastolic Blood Pressure at 15 Minutes
72.6897 milimeters of Hg
Standard Deviation 6.876998142
74.8 milimeters of Hg
Standard Deviation 9.672154605
74.8125 milimeters of Hg
Standard Deviation 13.17729597
80.0333 milimeters of Hg
Standard Deviation 13.86217876
69.3636 milimeters of Hg
Standard Deviation 9.800609576
72.5 milimeters of Hg
Standard Deviation 7.163066648
79 milimeters of Hg
Standard Deviation 15.45374329
74.1818 milimeters of Hg
Standard Deviation 11.57434093

PRIMARY outcome

Timeframe: 20th minute

Diastolic blood pressure values 15 minutes after local anesthesia injection

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diastolic Blood Pressure at 20 Minutes
71.6897 milimeters of Hg
Standard Deviation 7.865400945
74.1667 milimeters of Hg
Standard Deviation 9.013718791
74.1563 milimeters of Hg
Standard Deviation 11.65390527
80.8333 milimeters of Hg
Standard Deviation 13.56465997
69.4545 milimeters of Hg
Standard Deviation 6.200823853
75.9545 milimeters of Hg
Standard Deviation 8.566141948
77 milimeters of Hg
Standard Deviation 9.060403362
76.0455 milimeters of Hg
Standard Deviation 14.81144111

PRIMARY outcome

Timeframe: 35th minute

Diastolic blood pressure values 30 minutes after local anesthesia injection

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diastolic Blood Pressure at 35 Minutes
70.1379 milimeters of Hg
Standard Deviation 8.140393716
74.3667 milimeters of Hg
Standard Deviation 10.37021597
73.2813 milimeters of Hg
Standard Deviation 12.59091935
75.9 milimeters of Hg
Standard Deviation 12.29859279
69.1364 milimeters of Hg
Standard Deviation 7.146730552
77.0455 milimeters of Hg
Standard Deviation 7.587441207
77.6087 milimeters of Hg
Standard Deviation 7.19051857
74.7273 milimeters of Hg
Standard Deviation 8.446931357

PRIMARY outcome

Timeframe: baseline, 0 minutes

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Baseline Values of Heart Rate
75.0345 beats per minute
Standard Deviation 10.80172856
80.7727 beats per minute
Standard Deviation 6.682366571
78.3438 beats per minute
Standard Deviation 10.20312847
84.2581 beats per minute
Standard Deviation 13.16806172
76.4545 beats per minute
Standard Deviation 14.44769638
73.0333 beats per minute
Standard Deviation 8.695547948
76.2174 beats per minute
Standard Deviation 14.04031463
76.3636 beats per minute
Standard Deviation 9.756782523

PRIMARY outcome

Timeframe: 10th minute

Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Heart Rate at 10 Minutes
75.3448 beats per minute
Standard Deviation 11.45262248
81.7727 beats per minute
Standard Deviation 5.72311305
83.3125 beats per minute
Standard Deviation 10.35012077
88.5806 beats per minute
Standard Deviation 12.72209153
74.0455 beats per minute
Standard Deviation 15.06012481
73.0667 beats per minute
Standard Deviation 7.671417688
83.913 beats per minute
Standard Deviation 14.36811358
83.6818 beats per minute
Standard Deviation 13.23554508

PRIMARY outcome

Timeframe: 15th minute

Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Heart Rate at 15 Minutes
73.0345 beats per minute
Standard Deviation 10.10828076
77.4545 beats per minute
Standard Deviation 6.790883003
83.4688 beats per minute
Standard Deviation 10.92196477
86.8387 beats per minute
Standard Deviation 12.41261932
74.5 beats per minute
Standard Deviation 12.91271061
73.4333 beats per minute
Standard Deviation 4.896327805
81.6957 beats per minute
Standard Deviation 14.48974013
83.5909 beats per minute
Standard Deviation 11.09121957

PRIMARY outcome

Timeframe: 20th minute

Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Heart Rate at 20 Minutes
72.2414 beats per minute
Standard Deviation 9.697772839
80.2273 beats per minute
Standard Deviation 7.276477612
81.3125 beats per minute
Standard Deviation 11.56032565
86.1935 beats per minute
Standard Deviation 12.04552297
73.6818 beats per minute
Standard Deviation 12.32645766
71.8667 beats per minute
Standard Deviation 5.281881142
79.8435 beats per minute
Standard Deviation 13.46448997
82 beats per minute
Standard Deviation 11.84824681

PRIMARY outcome

Timeframe: 35th minute

Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Ceart Rate at 35 Minutes
72.1034 beats per minute
Standard Deviation 9.236359934
80.8182 beats per minute
Standard Deviation 6.095127129
80.0938 beats per minute
Standard Deviation 11.04348991
85.3871 beats per minute
Standard Deviation 11.87062879
71.3636 beats per minute
Standard Deviation 12.53393662
73.4333 beats per minute
Standard Deviation 7.762157062
77 beats per minute
Standard Deviation 13.78017709
78.2273 beats per minute
Standard Deviation 12.75382974

PRIMARY outcome

Timeframe: baseline, 0 minutes

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Baseline Electrocardiogram
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 10th minute

ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Electrocardiogram at 10 Minutes
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 15th minute

ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Electrocardiogram at 15 Minutes
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 20th minute

ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Electrocardiogram at 20 Minutes
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 10 minutes, until subjective feeling of soft tissue numbnes

Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Onset of Intraoral Local Anesthesia
1.76 minutes
Standard Deviation 0.87
5.27 minutes
Standard Deviation 2.12
2.16 minutes
Standard Deviation 1.08
5.45 minutes
Standard Deviation 2.64
2.77 minutes
Standard Deviation 1.11
4.59 minutes
Standard Deviation 2.58
2.83 minutes
Standard Deviation 0.83
6.36 minutes
Standard Deviation 2.3

SECONDARY outcome

Timeframe: Up to 10 minutes after injection of local anesthesia

Soft tissue numbness area determined by pin-prick test after maxillary infiltration anesthesia. Not tested for mandibular ablock anesthesia.

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Width of Anesthetic Field After Maxillary Infiltration Anesthesia
27.07 milimeters
Standard Deviation 1.06
NA milimeters
Standard Deviation NA
Measured only after infiltration technique
35.19 milimeters
Standard Deviation 1.67
NA milimeters
Standard Deviation NA
Measured only after infiltration technique
23.81 milimeters
Standard Deviation 1.07
NA milimeters
Standard Deviation NA
Measured only after infiltration technique
24.52 milimeters
Standard Deviation 0.95
NA milimeters
Standard Deviation NA
Measured only after infiltration technique

SECONDARY outcome

Timeframe: up to 24 hours after tooth extraction

Number of participants who experienced postoperative pain, VAS, NRS

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Postoperative Analgesia
11 Participants
15 Participants
13 Participants
14 Participants
5 Participants
14 Participants
10 Participants
12 Participants

SECONDARY outcome

Timeframe: 24 hours, 7 days

Postoperative paresthesia by clinical examination

Outcome measures

Outcome measures
Measure
Diabetics: L+C Maxillary Anesthesia
n=29 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+C Mandibular Anesthesia
n=30 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Diabetics: L+E Maxillary Anesthesia
n=32 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Diabetics: L+E Mandibular Anesthesia
n=31 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+C Maxillary Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+C Mandibular Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
Healthy: L+E Maxillary Anesthesia
n=25 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Healthy: L+E Mandibular Anesthesia
n=24 Participants
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Local Postoperative Complications
1 Participants
1 Participants
6 Participants
4 Participants
0 Participants
0 Participants
0 Participants
0 Participants

Adverse Events

Diabetics: L+C Maxillary Anesthesia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Diabetics: L+C Mandibular Anesthesia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Diabetics: L+E Maxillary Anesthesia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Diabetics: L+E Mandibular Anesthesia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy: L+C Maxillary Anesthesia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy: L+C Mandibular Anesthesia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy: L+E Maxillary Anesthesia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy: L+E Mandibular Anesthesia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

DDS PhD Professor Dragica Stojic, DDS PhD Professor Bozidar Brkovic, DDS PhD Marija Milic

University of Belgrade, Faculty of Dental Medicine

Phone: + 381 11 2685 280

Results disclosure agreements

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