Diabetes Mellitus, Local Anesthesia
Conditions
Brief summary
The purpose of this study is to determine whether 2% lidocaine (L) + clonidine (C) (15 mcg/ml) as a vasoconstrictor achieves efficient (equal or better parameters of intraoral local anesthesia in comparison to 2% lidocaine + epinephrine (E) (1:80 000)) and safe (stable cardiovascular parameters - systolic, diastolic, mean blood pressure and heart rate) intraoral local anesthesia in patients with Diabetes mellitus type 2.
Detailed description
Patients with diabetes mellitus type 2, represent a risk for performing regional anesthesia techniques due to microvascular (microangiopathy, neuropathy) and macrovascular (hypertension, coronary heart disease) complications. There is evidence that local anesthetic toxicity may be increased in diabetic setting due to underlying neuropathy; while interaction of diabetic blood vessels with vasoconstrictors may be of importance because of microangiopathic changes. Lately, regional anesthesia protocol in general surgery for patients with diabetes mellitus was released, proposing reduction of local anesthetic concentration and avoiding epinephrine as vasoconstrictor. Oral cavity tissues in diabetes mellitus also suffer from neuropathy (burning, paresthesia, teeth loss, temporomandibular dysfunction, xerostomia) and microangiopathy (periodontal disease, salivary gland dysfunction). Most widely used vasoconstrictor for intraoral local anesthesia, epinephrine, is an alpha- and beta- adrenergic agonist. Because of its beta-adrenergic effects, epinephrine could adversely affect cardiovascular function, especially in risk patients. There are data suggesting that intraoral local anesthesia obtained with 2% lidocaine with clonidine, selective alpha 2-adrenoceptor agonist as a vasoconstrictor, is characterized with significantly more stable cardiovascular parameters and similar parameters of local anesthesia with respect to lidocaine with epinephrine in healthy and hypertensive patients. With regard to aforementioned, the aim of this randomized double-blind controlled clinical trial is to evaluate and compare efficacy and safety of intraoral local anesthesia obtained with 2% lidocaine (L) + clonidine (15 mcg/ml) (C) or 2% L + epinephrine (1:80 000) (E), comparing healthy and diabetes mellitus type 2 patients. Prior to tooth extraction, random allocation to one of four groups (L+C maxillary infiltration, L+C mandibular block, L+E maxillary infiltration and L+E mandibular block) is performed for diabetic (30 per group) and healthy (30 per group) patients. Parameters of local anesthesia (onset, duration, intensity, width of anesthetic field for maxillary infiltration), cardiovascular parameters (systolic, diastolic, mean arterial pressure; heart rate and electrocardiographic changes), quality of postoperative analgesia (assessed by Visual Analogue Scale, Numerical Rating Scale and number of consumed analgesics) and postoperative complications (infection, bleeding, paresthesia, delayed wound healing) are evaluated and compared.
Interventions
DRUGL+C maxillary anesthesia
Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
DRUGL+C mandibular anesthesia
Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
DRUGL+E maxillary anesthesia
Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
DRUGL+E mandibular anesthesia
Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Sponsors
University of Belgrade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Healthy participants: ASA I * Diabetic type 2 participants: ASA III (HbA1c level \< 9%) * Required a single-root teeth indicated for non-complicated extraction * Dental diagnosis of periodontal disease, tooth fracture, chronic periapical lesion and root infection * Subjects give informed written consent
Exclusion criteria
* Pregnancy and lactation * Allergy to used drugs and food * Hepatic and/or renal failure * ASA IV patients * Tobacco smokers * History of alcoholism and/or drug abuse and addiction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiogram at 20 Minutes | 20th minute | ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement |
| Ceart Rate at 35 Minutes | 35th minute | Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement |
| Baseline Electrocardiogram | baseline, 0 minutes | — |
| Electrocardiogram at 10 Minutes | 10th minute | ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement |
| Electrocardiogram at 15 Minutes | 15th minute | ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement |
| Duration of Intraoral Local Anesthesia | Up to 6 hours after local anesthesia injection | Time until cessation in soft tissue numbness |
| Intensity of Intraoral Local Anesthesia | 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. |
| Baseline Systolic Blood Pressure | Baseline, 0 minutes | — |
| Systolic Blood Pressure at 10 Minutes | 10th minute | Systolic blood pressure values 5 minutes after local anesthesia injection |
| Systolic Blood Pressure at 15 Minutes | 15th minute | Systolic blood pressure values 10 minutes after local anesthesia injection |
| Systolic Blood Pressure at 20 Minutes | 20th minute | Systolic blood pressure values 15 minutes after local anesthesia injection |
| Systolic Blood Pressure at 35 Minutes | 35th minute | Systolic blood pressure values 30 minutes after local anesthesia injection |
| Baseline Diastolic Blood Pressure | baseline, 0 minutes | — |
| Diastolic Blood Pressure at 10 Minutes | 10th minute | Diastolic blood pressure values 5 minutes after local anesthesia injection |
| Diastolic Blood Pressure at 15 Minutes | 15th minute | Diastolic blood pressure values 10 minutes after local anesthesia injection |
| Diastolic Blood Pressure at 20 Minutes | 20th minute | Diastolic blood pressure values 15 minutes after local anesthesia injection |
| Diastolic Blood Pressure at 35 Minutes | 35th minute | Diastolic blood pressure values 30 minutes after local anesthesia injection |
| Baseline Values of Heart Rate | baseline, 0 minutes | — |
| Heart Rate at 10 Minutes | 10th minute | Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement |
| Heart Rate at 15 Minutes | 15th minute | Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement |
| Heart Rate at 20 Minutes | 20th minute | Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Width of Anesthetic Field After Maxillary Infiltration Anesthesia | 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. |
| Postoperative Analgesia | up to 24 hours after tooth extraction | Number of participants who experienced postoperative pain, VAS, NRS |
| Local Postoperative Complications | 24 hours, 7 days | Postoperative paresthesia by clinical examination |
| Onset of Intraoral Local Anesthesia | 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 |
Countries
Serbia
Participant flow
Recruitment details
Participants recruited between june 2013 and december 2015 among the patients of Clinic of Oral Surgery, Faculty of Dental Medicine, University of Belgrade
Participants by arm
| Arm | Count |
|---|---|
| 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) | 29 |
| 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) | 30 |
| 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) | 32 |
| 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) | 31 |
| 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) | 24 |
| 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) | 25 |
| 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) | 25 |
| 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) | 24 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| 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
| Characteristic | Total | Diabetics: L+C Mandibular Anesthesia | Diabetics: L+C Maxillary Anesthesia | Diabetics: L+E Maxillary Anesthesia | Diabetics: L+E Mandibular Anesthesia | Healthy: L+C Maxillary Anesthesia | Healthy: L+C Mandibular Anesthesia | Healthy: L+E Maxillary Anesthesia | Healthy: L+E Mandibular Anesthesia |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 220 Participants | 30 Participants | 29 Participants | 32 Participants | 31 Participants | 24 Participants | 25 Participants | 25 Participants | 24 Participants |
| Body Mass | 76.90 kilograms STANDARD_DEVIATION 8.42 | 75.03 kilograms STANDARD_DEVIATION 11.53 | 78.72 kilograms STANDARD_DEVIATION 11.19 | 85.84 kilograms STANDARD_DEVIATION 14.76 | 79.45 kilograms STANDARD_DEVIATION 17.34 | 79.50 kilograms STANDARD_DEVIATION 15.22 | 74.59 kilograms STANDARD_DEVIATION 9.64 | 71.01 kilograms STANDARD_DEVIATION 12.08 | 71.59 kilograms STANDARD_DEVIATION 7.81 |
| Coronary Artery Disease | NA Participants | 14 Participants | 12 Participants | 14 Participants | 13 Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Duration of Diabetes | NA years | 9.57 years STANDARD_DEVIATION 5.51 | 6.83 years STANDARD_DEVIATION 4.59 | 9.77 years STANDARD_DEVIATION 7.62 | 9.27 years STANDARD_DEVIATION 6.09 | NA years | NA years | NA years | NA years |
| Fasting Plasma Glucose | NA milimoles per liter | 7.55 milimoles per liter STANDARD_DEVIATION 2.53 | 8.12 milimoles per liter STANDARD_DEVIATION 3.01 | 9.66 milimoles per liter STANDARD_DEVIATION 4.02 | 8.35 milimoles per liter STANDARD_DEVIATION 2.49 | NA milimoles per liter | NA milimoles per liter | NA milimoles per liter | NA milimoles per liter |
| Glycosilated Hemoglobin | NA percents | 7.55 percents STANDARD_DEVIATION 2.53 | 7.42 percents STANDARD_DEVIATION 1.25 | 7.63 percents STANDARD_DEVIATION 1.72 | 7.97 percents STANDARD_DEVIATION 1.5 | NA percents | NA percents | NA percents | NA percents |
| Hypertension | NA Participants | 26 Participants | 16 Participants | 19 Participants | 17 Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Intraoral Neuropathy | NA Participants | 16 Participants | 14 Participants | 17 Participants | 18 Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Number of participants on insulin therapy | NA Participants | 4 Participants | 2 Participants | 8 Participants | 4 Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Number of participants on OHA therapy | NA Participants | 29 Participants | 28 Participants | 30 Participants | 30 Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Number of participants with modified diet | NA Participants | 30 Participants | 22 Participants | 31 Participants | 30 Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Peripheral Neuropathy | NA Participants | 12 Participants | 9 Participants | 12 Participants | 10 Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Region of Enrollment Serbia | 220 participants | 31 participants | 32 participants | 33 participants | 31 participants | 24 participants | 25 participants | 25 participants | 24 participants |
| Sex: Female, Male Female | 126 Participants | 16 Participants | 22 Participants | 21 Participants | 14 Participants | 9 Participants | 15 Participants | 15 Participants | 14 Participants |
| Sex: Female, Male Male | 94 Participants | 14 Participants | 7 Participants | 11 Participants | 17 Participants | 15 Participants | 10 Participants | 10 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 30 | 0 / 32 | 0 / 31 | 0 / 24 | 0 / 25 | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 | 0 / 32 | 0 / 31 | 0 / 24 | 0 / 25 | 0 / 25 | 0 / 24 |
Outcome results
Primary
Baseline Diastolic Blood Pressure
Time frame: baseline, 0 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Baseline Diastolic Blood Pressure | 74.1379 milimeters of Hg | Standard Deviation 11.37894088 |
| Diabetics: L+C Mandibular Anesthesia | Baseline Diastolic Blood Pressure | 81.7667 milimeters of Hg | Standard Deviation 9.722648048 |
| Diabetics: L+E Maxillary Anesthesia | Baseline Diastolic Blood Pressure | 75.25 milimeters of Hg | Standard Deviation 12.09372004 |
| Diabetics: L+E Mandibular Anesthesia | Baseline Diastolic Blood Pressure | 79.2 milimeters of Hg | Standard Deviation 15.61345574 |
| Healthy: L+C Maxillary Anesthesia | Baseline Diastolic Blood Pressure | 73.1364 milimeters of Hg | Standard Deviation 9.627814144 |
| Healthy: L+C Mandibular Anesthesia | Baseline Diastolic Blood Pressure | 80.9545 milimeters of Hg | Standard Deviation 11.23547644 |
| Healthy: L+E Maxillary Anesthesia | Baseline Diastolic Blood Pressure | 76.3913 milimeters of Hg | Standard Deviation 5.694807287 |
| Healthy: L+E Mandibular Anesthesia | Baseline Diastolic Blood Pressure | 75.0909 milimeters of Hg | Standard Deviation 12.72758194 |
Primary
Baseline Electrocardiogram
Time frame: baseline, 0 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Baseline Electrocardiogram | 0 Participants |
| Diabetics: L+C Mandibular Anesthesia | Baseline Electrocardiogram | 0 Participants |
| Diabetics: L+E Maxillary Anesthesia | Baseline Electrocardiogram | 0 Participants |
| Diabetics: L+E Mandibular Anesthesia | Baseline Electrocardiogram | 0 Participants |
| Healthy: L+C Maxillary Anesthesia | Baseline Electrocardiogram | 0 Participants |
| Healthy: L+C Mandibular Anesthesia | Baseline Electrocardiogram | 0 Participants |
| Healthy: L+E Maxillary Anesthesia | Baseline Electrocardiogram | 0 Participants |
| Healthy: L+E Mandibular Anesthesia | Baseline Electrocardiogram | 0 Participants |
p-value: <0.05Chi-squared
Primary
Baseline Systolic Blood Pressure
Time frame: Baseline, 0 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Baseline Systolic Blood Pressure | 135.2759 milimeters of Hg | Standard Deviation 16.69665611 |
| Diabetics: L+C Mandibular Anesthesia | Baseline Systolic Blood Pressure | 137.7333 milimeters of Hg | Standard Deviation 18.43335308 |
| Diabetics: L+E Maxillary Anesthesia | Baseline Systolic Blood Pressure | 134.8125 milimeters of Hg | Standard Deviation 18.66934265 |
| Diabetics: L+E Mandibular Anesthesia | Baseline Systolic Blood Pressure | 134.4667 milimeters of Hg | Standard Deviation 17.69119729 |
| Healthy: L+C Maxillary Anesthesia | Baseline Systolic Blood Pressure | 124.0455 milimeters of Hg | Standard Deviation 11.07325079 |
| Healthy: L+C Mandibular Anesthesia | Baseline Systolic Blood Pressure | 128.1818 milimeters of Hg | Standard Deviation 15.49388931 |
| Healthy: L+E Maxillary Anesthesia | Baseline Systolic Blood Pressure | 125 milimeters of Hg | Standard Deviation 11.11918898 |
| Healthy: L+E Mandibular Anesthesia | Baseline Systolic Blood Pressure | 126.5909 milimeters of Hg | Standard Deviation 18.82322642 |
Primary
Baseline Values of Heart Rate
Time frame: baseline, 0 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Baseline Values of Heart Rate | 75.0345 beats per minute | Standard Deviation 10.80172856 |
| Diabetics: L+C Mandibular Anesthesia | Baseline Values of Heart Rate | 80.7727 beats per minute | Standard Deviation 6.682366571 |
| Diabetics: L+E Maxillary Anesthesia | Baseline Values of Heart Rate | 78.3438 beats per minute | Standard Deviation 10.20312847 |
| Diabetics: L+E Mandibular Anesthesia | Baseline Values of Heart Rate | 84.2581 beats per minute | Standard Deviation 13.16806172 |
| Healthy: L+C Maxillary Anesthesia | Baseline Values of Heart Rate | 76.4545 beats per minute | Standard Deviation 14.44769638 |
| Healthy: L+C Mandibular Anesthesia | Baseline Values of Heart Rate | 73.0333 beats per minute | Standard Deviation 8.695547948 |
| Healthy: L+E Maxillary Anesthesia | Baseline Values of Heart Rate | 76.2174 beats per minute | Standard Deviation 14.04031463 |
| Healthy: L+E Mandibular Anesthesia | Baseline Values of Heart Rate | 76.3636 beats per minute | Standard Deviation 9.756782523 |
Primary
Ceart Rate at 35 Minutes
Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement
Time frame: 35th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Ceart Rate at 35 Minutes | 72.1034 beats per minute | Standard Deviation 9.236359934 |
| Diabetics: L+C Mandibular Anesthesia | Ceart Rate at 35 Minutes | 80.8182 beats per minute | Standard Deviation 6.095127129 |
| Diabetics: L+E Maxillary Anesthesia | Ceart Rate at 35 Minutes | 80.0938 beats per minute | Standard Deviation 11.04348991 |
| Diabetics: L+E Mandibular Anesthesia | Ceart Rate at 35 Minutes | 85.3871 beats per minute | Standard Deviation 11.87062879 |
| Healthy: L+C Maxillary Anesthesia | Ceart Rate at 35 Minutes | 71.3636 beats per minute | Standard Deviation 12.53393662 |
| Healthy: L+C Mandibular Anesthesia | Ceart Rate at 35 Minutes | 73.4333 beats per minute | Standard Deviation 7.762157062 |
| Healthy: L+E Maxillary Anesthesia | Ceart Rate at 35 Minutes | 77 beats per minute | Standard Deviation 13.78017709 |
| Healthy: L+E Mandibular Anesthesia | Ceart Rate at 35 Minutes | 78.2273 beats per minute | Standard Deviation 12.75382974 |
Primary
Diastolic Blood Pressure at 10 Minutes
Diastolic blood pressure values 5 minutes after local anesthesia injection
Time frame: 10th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Diastolic Blood Pressure at 10 Minutes | 74.0345 milimeters of Hg | Standard Deviation 8.398480979 |
| Diabetics: L+C Mandibular Anesthesia | Diastolic Blood Pressure at 10 Minutes | 75.3667 milimeters of Hg | Standard Deviation 12.09830424 |
| Diabetics: L+E Maxillary Anesthesia | Diastolic Blood Pressure at 10 Minutes | 75.6875 milimeters of Hg | Standard Deviation 14.74829132 |
| Diabetics: L+E Mandibular Anesthesia | Diastolic Blood Pressure at 10 Minutes | 79.1 milimeters of Hg | Standard Deviation 15.23497999 |
| Healthy: L+C Maxillary Anesthesia | Diastolic Blood Pressure at 10 Minutes | 69.7273 milimeters of Hg | Standard Deviation 10.49798991 |
| Healthy: L+C Mandibular Anesthesia | Diastolic Blood Pressure at 10 Minutes | 75.0909 milimeters of Hg | Standard Deviation 6.560408603 |
| Healthy: L+E Maxillary Anesthesia | Diastolic Blood Pressure at 10 Minutes | 75.8261 milimeters of Hg | Standard Deviation 7.010720193 |
| Healthy: L+E Mandibular Anesthesia | Diastolic Blood Pressure at 10 Minutes | 73.8636 milimeters of Hg | Standard Deviation 10.14793178 |
Primary
Diastolic Blood Pressure at 15 Minutes
Diastolic blood pressure values 10 minutes after local anesthesia injection
Time frame: 15th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Diastolic Blood Pressure at 15 Minutes | 72.6897 milimeters of Hg | Standard Deviation 6.876998142 |
| Diabetics: L+C Mandibular Anesthesia | Diastolic Blood Pressure at 15 Minutes | 74.8 milimeters of Hg | Standard Deviation 9.672154605 |
| Diabetics: L+E Maxillary Anesthesia | Diastolic Blood Pressure at 15 Minutes | 74.8125 milimeters of Hg | Standard Deviation 13.17729597 |
| Diabetics: L+E Mandibular Anesthesia | Diastolic Blood Pressure at 15 Minutes | 80.0333 milimeters of Hg | Standard Deviation 13.86217876 |
| Healthy: L+C Maxillary Anesthesia | Diastolic Blood Pressure at 15 Minutes | 69.3636 milimeters of Hg | Standard Deviation 9.800609576 |
| Healthy: L+C Mandibular Anesthesia | Diastolic Blood Pressure at 15 Minutes | 72.5 milimeters of Hg | Standard Deviation 7.163066648 |
| Healthy: L+E Maxillary Anesthesia | Diastolic Blood Pressure at 15 Minutes | 79 milimeters of Hg | Standard Deviation 15.45374329 |
| Healthy: L+E Mandibular Anesthesia | Diastolic Blood Pressure at 15 Minutes | 74.1818 milimeters of Hg | Standard Deviation 11.57434093 |
Primary
Diastolic Blood Pressure at 20 Minutes
Diastolic blood pressure values 15 minutes after local anesthesia injection
Time frame: 20th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Diastolic Blood Pressure at 20 Minutes | 71.6897 milimeters of Hg | Standard Deviation 7.865400945 |
| Diabetics: L+C Mandibular Anesthesia | Diastolic Blood Pressure at 20 Minutes | 74.1667 milimeters of Hg | Standard Deviation 9.013718791 |
| Diabetics: L+E Maxillary Anesthesia | Diastolic Blood Pressure at 20 Minutes | 74.1563 milimeters of Hg | Standard Deviation 11.65390527 |
| Diabetics: L+E Mandibular Anesthesia | Diastolic Blood Pressure at 20 Minutes | 80.8333 milimeters of Hg | Standard Deviation 13.56465997 |
| Healthy: L+C Maxillary Anesthesia | Diastolic Blood Pressure at 20 Minutes | 69.4545 milimeters of Hg | Standard Deviation 6.200823853 |
| Healthy: L+C Mandibular Anesthesia | Diastolic Blood Pressure at 20 Minutes | 75.9545 milimeters of Hg | Standard Deviation 8.566141948 |
| Healthy: L+E Maxillary Anesthesia | Diastolic Blood Pressure at 20 Minutes | 77 milimeters of Hg | Standard Deviation 9.060403362 |
| Healthy: L+E Mandibular Anesthesia | Diastolic Blood Pressure at 20 Minutes | 76.0455 milimeters of Hg | Standard Deviation 14.81144111 |
Primary
Diastolic Blood Pressure at 35 Minutes
Diastolic blood pressure values 30 minutes after local anesthesia injection
Time frame: 35th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Diastolic Blood Pressure at 35 Minutes | 70.1379 milimeters of Hg | Standard Deviation 8.140393716 |
| Diabetics: L+C Mandibular Anesthesia | Diastolic Blood Pressure at 35 Minutes | 74.3667 milimeters of Hg | Standard Deviation 10.37021597 |
| Diabetics: L+E Maxillary Anesthesia | Diastolic Blood Pressure at 35 Minutes | 73.2813 milimeters of Hg | Standard Deviation 12.59091935 |
| Diabetics: L+E Mandibular Anesthesia | Diastolic Blood Pressure at 35 Minutes | 75.9 milimeters of Hg | Standard Deviation 12.29859279 |
| Healthy: L+C Maxillary Anesthesia | Diastolic Blood Pressure at 35 Minutes | 69.1364 milimeters of Hg | Standard Deviation 7.146730552 |
| Healthy: L+C Mandibular Anesthesia | Diastolic Blood Pressure at 35 Minutes | 77.0455 milimeters of Hg | Standard Deviation 7.587441207 |
| Healthy: L+E Maxillary Anesthesia | Diastolic Blood Pressure at 35 Minutes | 77.6087 milimeters of Hg | Standard Deviation 7.19051857 |
| Healthy: L+E Mandibular Anesthesia | Diastolic Blood Pressure at 35 Minutes | 74.7273 milimeters of Hg | Standard Deviation 8.446931357 |
Primary
Duration of Intraoral Local Anesthesia
Time until cessation in soft tissue numbness
Time frame: Up to 6 hours after local anesthesia injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Duration of Intraoral Local Anesthesia | 132.48 minutes | Standard Deviation 91.86 |
| Diabetics: L+C Mandibular Anesthesia | Duration of Intraoral Local Anesthesia | 173.27 minutes | Standard Deviation 70.44 |
| Diabetics: L+E Maxillary Anesthesia | Duration of Intraoral Local Anesthesia | 182.09 minutes | Standard Deviation 57.86 |
| Diabetics: L+E Mandibular Anesthesia | Duration of Intraoral Local Anesthesia | 195.35 minutes | Standard Deviation 68.99 |
| Healthy: L+C Maxillary Anesthesia | Duration of Intraoral Local Anesthesia | 108.82 minutes | Standard Deviation 27.76 |
| Healthy: L+C Mandibular Anesthesia | Duration of Intraoral Local Anesthesia | 155.59 minutes | Standard Deviation 60.75 |
| Healthy: L+E Maxillary Anesthesia | Duration of Intraoral Local Anesthesia | 114.74 minutes | Standard Deviation 39.72 |
| Healthy: L+E Mandibular Anesthesia | Duration of Intraoral Local Anesthesia | 172.91 minutes | Standard Deviation 68.93 |
Comparison: In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each groupp-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Electrocardiogram at 10 Minutes
ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Time frame: 10th minute
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Electrocardiogram at 10 Minutes | 0 Participants |
| Diabetics: L+C Mandibular Anesthesia | Electrocardiogram at 10 Minutes | 0 Participants |
| Diabetics: L+E Maxillary Anesthesia | Electrocardiogram at 10 Minutes | 0 Participants |
| Diabetics: L+E Mandibular Anesthesia | Electrocardiogram at 10 Minutes | 0 Participants |
| Healthy: L+C Maxillary Anesthesia | Electrocardiogram at 10 Minutes | 0 Participants |
| Healthy: L+C Mandibular Anesthesia | Electrocardiogram at 10 Minutes | 0 Participants |
| Healthy: L+E Maxillary Anesthesia | Electrocardiogram at 10 Minutes | 0 Participants |
| Healthy: L+E Mandibular Anesthesia | Electrocardiogram at 10 Minutes | 0 Participants |
p-value: <0.05Chi-squared
Primary
Electrocardiogram at 15 Minutes
ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Time frame: 15th minute
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Electrocardiogram at 15 Minutes | 0 Participants |
| Diabetics: L+C Mandibular Anesthesia | Electrocardiogram at 15 Minutes | 0 Participants |
| Diabetics: L+E Maxillary Anesthesia | Electrocardiogram at 15 Minutes | 0 Participants |
| Diabetics: L+E Mandibular Anesthesia | Electrocardiogram at 15 Minutes | 0 Participants |
| Healthy: L+C Maxillary Anesthesia | Electrocardiogram at 15 Minutes | 0 Participants |
| Healthy: L+C Mandibular Anesthesia | Electrocardiogram at 15 Minutes | 0 Participants |
| Healthy: L+E Maxillary Anesthesia | Electrocardiogram at 15 Minutes | 0 Participants |
| Healthy: L+E Mandibular Anesthesia | Electrocardiogram at 15 Minutes | 0 Participants |
p-value: <0.05Chi-squared
Primary
Electrocardiogram at 20 Minutes
ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
Time frame: 20th minute
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Electrocardiogram at 20 Minutes | 0 Participants |
| Diabetics: L+C Mandibular Anesthesia | Electrocardiogram at 20 Minutes | 0 Participants |
| Diabetics: L+E Maxillary Anesthesia | Electrocardiogram at 20 Minutes | 0 Participants |
| Diabetics: L+E Mandibular Anesthesia | Electrocardiogram at 20 Minutes | 0 Participants |
| Healthy: L+C Maxillary Anesthesia | Electrocardiogram at 20 Minutes | 0 Participants |
| Healthy: L+C Mandibular Anesthesia | Electrocardiogram at 20 Minutes | 0 Participants |
| Healthy: L+E Maxillary Anesthesia | Electrocardiogram at 20 Minutes | 0 Participants |
| Healthy: L+E Mandibular Anesthesia | Electrocardiogram at 20 Minutes | 0 Participants |
p-value: <0.05Chi-squared
Primary
Heart Rate at 10 Minutes
Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Time frame: 10th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Heart Rate at 10 Minutes | 75.3448 beats per minute | Standard Deviation 11.45262248 |
| Diabetics: L+C Mandibular Anesthesia | Heart Rate at 10 Minutes | 81.7727 beats per minute | Standard Deviation 5.72311305 |
| Diabetics: L+E Maxillary Anesthesia | Heart Rate at 10 Minutes | 83.3125 beats per minute | Standard Deviation 10.35012077 |
| Diabetics: L+E Mandibular Anesthesia | Heart Rate at 10 Minutes | 88.5806 beats per minute | Standard Deviation 12.72209153 |
| Healthy: L+C Maxillary Anesthesia | Heart Rate at 10 Minutes | 74.0455 beats per minute | Standard Deviation 15.06012481 |
| Healthy: L+C Mandibular Anesthesia | Heart Rate at 10 Minutes | 73.0667 beats per minute | Standard Deviation 7.671417688 |
| Healthy: L+E Maxillary Anesthesia | Heart Rate at 10 Minutes | 83.913 beats per minute | Standard Deviation 14.36811358 |
| Healthy: L+E Mandibular Anesthesia | Heart Rate at 10 Minutes | 83.6818 beats per minute | Standard Deviation 13.23554508 |
Primary
Heart Rate at 15 Minutes
Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Time frame: 15th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Heart Rate at 15 Minutes | 73.0345 beats per minute | Standard Deviation 10.10828076 |
| Diabetics: L+C Mandibular Anesthesia | Heart Rate at 15 Minutes | 77.4545 beats per minute | Standard Deviation 6.790883003 |
| Diabetics: L+E Maxillary Anesthesia | Heart Rate at 15 Minutes | 83.4688 beats per minute | Standard Deviation 10.92196477 |
| Diabetics: L+E Mandibular Anesthesia | Heart Rate at 15 Minutes | 86.8387 beats per minute | Standard Deviation 12.41261932 |
| Healthy: L+C Maxillary Anesthesia | Heart Rate at 15 Minutes | 74.5 beats per minute | Standard Deviation 12.91271061 |
| Healthy: L+C Mandibular Anesthesia | Heart Rate at 15 Minutes | 73.4333 beats per minute | Standard Deviation 4.896327805 |
| Healthy: L+E Maxillary Anesthesia | Heart Rate at 15 Minutes | 81.6957 beats per minute | Standard Deviation 14.48974013 |
| Healthy: L+E Mandibular Anesthesia | Heart Rate at 15 Minutes | 83.5909 beats per minute | Standard Deviation 11.09121957 |
Primary
Heart Rate at 20 Minutes
Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
Time frame: 20th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Heart Rate at 20 Minutes | 72.2414 beats per minute | Standard Deviation 9.697772839 |
| Diabetics: L+C Mandibular Anesthesia | Heart Rate at 20 Minutes | 80.2273 beats per minute | Standard Deviation 7.276477612 |
| Diabetics: L+E Maxillary Anesthesia | Heart Rate at 20 Minutes | 81.3125 beats per minute | Standard Deviation 11.56032565 |
| Diabetics: L+E Mandibular Anesthesia | Heart Rate at 20 Minutes | 86.1935 beats per minute | Standard Deviation 12.04552297 |
| Healthy: L+C Maxillary Anesthesia | Heart Rate at 20 Minutes | 73.6818 beats per minute | Standard Deviation 12.32645766 |
| Healthy: L+C Mandibular Anesthesia | Heart Rate at 20 Minutes | 71.8667 beats per minute | Standard Deviation 5.281881142 |
| Healthy: L+E Maxillary Anesthesia | Heart Rate at 20 Minutes | 79.8435 beats per minute | Standard Deviation 13.46448997 |
| Healthy: L+E Mandibular Anesthesia | Heart Rate at 20 Minutes | 82 beats per minute | Standard Deviation 11.84824681 |
Primary
Intensity of Intraoral Local Anesthesia
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.
Time frame: Up to 10 minutes after local anesthesia injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Intensity of Intraoral Local Anesthesia | 2 Participants |
| Diabetics: L+C Mandibular Anesthesia | Intensity of Intraoral Local Anesthesia | 2 Participants |
| Diabetics: L+E Maxillary Anesthesia | Intensity of Intraoral Local Anesthesia | 1 Participants |
| Diabetics: L+E Mandibular Anesthesia | Intensity of Intraoral Local Anesthesia | 8 Participants |
| Healthy: L+C Maxillary Anesthesia | Intensity of Intraoral Local Anesthesia | 2 Participants |
| Healthy: L+C Mandibular Anesthesia | Intensity of Intraoral Local Anesthesia | 1 Participants |
| Healthy: L+E Maxillary Anesthesia | Intensity of Intraoral Local Anesthesia | 4 Participants |
| Healthy: L+E Mandibular Anesthesia | Intensity of Intraoral Local Anesthesia | 6 Participants |
p-value: <0.05Chi-squared
Primary
Systolic Blood Pressure at 10 Minutes
Systolic blood pressure values 5 minutes after local anesthesia injection
Time frame: 10th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Systolic Blood Pressure at 10 Minutes | 130.3793 milimeters of Hg | Standard Deviation 18.81377496 |
| Diabetics: L+C Mandibular Anesthesia | Systolic Blood Pressure at 10 Minutes | 136.8333 milimeters of Hg | Standard Deviation 14.27098173 |
| Diabetics: L+E Maxillary Anesthesia | Systolic Blood Pressure at 10 Minutes | 137.4375 milimeters of Hg | Standard Deviation 19.73033934 |
| Diabetics: L+E Mandibular Anesthesia | Systolic Blood Pressure at 10 Minutes | 132.6 milimeters of Hg | Standard Deviation 20.45858857 |
| Healthy: L+C Maxillary Anesthesia | Systolic Blood Pressure at 10 Minutes | 120.8182 milimeters of Hg | Standard Deviation 13.58092627 |
| Healthy: L+C Mandibular Anesthesia | Systolic Blood Pressure at 10 Minutes | 122.5909 milimeters of Hg | Standard Deviation 14.59503859 |
| Healthy: L+E Maxillary Anesthesia | Systolic Blood Pressure at 10 Minutes | 125.8261 milimeters of Hg | Standard Deviation 13.75979708 |
| Healthy: L+E Mandibular Anesthesia | Systolic Blood Pressure at 10 Minutes | 125,4091 milimeters of Hg | Standard Deviation 12.71541656 |
Primary
Systolic Blood Pressure at 15 Minutes
Systolic blood pressure values 10 minutes after local anesthesia injection
Time frame: 15th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Systolic Blood Pressure at 15 Minutes | 133.5862 milimeters of Hg | Standard Deviation 13.51590925 |
| Diabetics: L+C Mandibular Anesthesia | Systolic Blood Pressure at 15 Minutes | 133.4667 milimeters of Hg | Standard Deviation 14.12684735 |
| Diabetics: L+E Maxillary Anesthesia | Systolic Blood Pressure at 15 Minutes | 137.4688 milimeters of Hg | Standard Deviation 19.28058421 |
| Diabetics: L+E Mandibular Anesthesia | Systolic Blood Pressure at 15 Minutes | 132.0667 milimeters of Hg | Standard Deviation 17.89580957 |
| Healthy: L+C Maxillary Anesthesia | Systolic Blood Pressure at 15 Minutes | 114.4545 milimeters of Hg | Standard Deviation 11.89128241 |
| Healthy: L+C Mandibular Anesthesia | Systolic Blood Pressure at 15 Minutes | 116.9091 milimeters of Hg | Standard Deviation 12.78730431 |
| Healthy: L+E Maxillary Anesthesia | Systolic Blood Pressure at 15 Minutes | 123.8696 milimeters of Hg | Standard Deviation 13.61250878 |
| Healthy: L+E Mandibular Anesthesia | Systolic Blood Pressure at 15 Minutes | 127.1818 milimeters of Hg | Standard Deviation 18.58733917 |
Primary
Systolic Blood Pressure at 20 Minutes
Systolic blood pressure values 15 minutes after local anesthesia injection
Time frame: 20th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Systolic Blood Pressure at 20 Minutes | 130.2414 milimeters of Hg | Standard Deviation 14.98011819 |
| Diabetics: L+C Mandibular Anesthesia | Systolic Blood Pressure at 20 Minutes | 131.3333 milimeters of Hg | Standard Deviation 14.73755076 |
| Diabetics: L+E Maxillary Anesthesia | Systolic Blood Pressure at 20 Minutes | 132.4063 milimeters of Hg | Standard Deviation 17.69428443 |
| Diabetics: L+E Mandibular Anesthesia | Systolic Blood Pressure at 20 Minutes | 133.2333 milimeters of Hg | Standard Deviation 18.46560212 |
| Healthy: L+C Maxillary Anesthesia | Systolic Blood Pressure at 20 Minutes | 108.8182 milimeters of Hg | Standard Deviation 9.529630256 |
| Healthy: L+C Mandibular Anesthesia | Systolic Blood Pressure at 20 Minutes | 120.8636 milimeters of Hg | Standard Deviation 12.995587 |
| Healthy: L+E Maxillary Anesthesia | Systolic Blood Pressure at 20 Minutes | 123.8696 milimeters of Hg | Standard Deviation 12.15918788 |
| Healthy: L+E Mandibular Anesthesia | Systolic Blood Pressure at 20 Minutes | 124.6818 milimeters of Hg | Standard Deviation 19.56767588 |
Primary
Systolic Blood Pressure at 35 Minutes
Systolic blood pressure values 30 minutes after local anesthesia injection
Time frame: 35th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Systolic Blood Pressure at 35 Minutes | 127.2759 milimeters of Hg | Standard Deviation 12.91979807 |
| Diabetics: L+C Mandibular Anesthesia | Systolic Blood Pressure at 35 Minutes | 130.3 milimeters of Hg | Standard Deviation 13.12841089 |
| Diabetics: L+E Maxillary Anesthesia | Systolic Blood Pressure at 35 Minutes | 132.5625 milimeters of Hg | Standard Deviation 17.0330561 |
| Diabetics: L+E Mandibular Anesthesia | Systolic Blood Pressure at 35 Minutes | 132.7 milimeters of Hg | Standard Deviation 16.38723706 |
| Healthy: L+C Maxillary Anesthesia | Systolic Blood Pressure at 35 Minutes | 116.3636 milimeters of Hg | Standard Deviation 7.364945637 |
| Healthy: L+C Mandibular Anesthesia | Systolic Blood Pressure at 35 Minutes | 120.1364 milimeters of Hg | Standard Deviation 14.54809906 |
| Healthy: L+E Maxillary Anesthesia | Systolic Blood Pressure at 35 Minutes | 120.6522 milimeters of Hg | Standard Deviation 10.01185069 |
| Healthy: L+E Mandibular Anesthesia | Systolic Blood Pressure at 35 Minutes | 126.4545 milimeters of Hg | Standard Deviation 17.25916533 |
Secondary
Local Postoperative Complications
Postoperative paresthesia by clinical examination
Time frame: 24 hours, 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Local Postoperative Complications | 1 Participants |
| Diabetics: L+C Mandibular Anesthesia | Local Postoperative Complications | 1 Participants |
| Diabetics: L+E Maxillary Anesthesia | Local Postoperative Complications | 6 Participants |
| Diabetics: L+E Mandibular Anesthesia | Local Postoperative Complications | 4 Participants |
| Healthy: L+C Maxillary Anesthesia | Local Postoperative Complications | 0 Participants |
| Healthy: L+C Mandibular Anesthesia | Local Postoperative Complications | 0 Participants |
| Healthy: L+E Maxillary Anesthesia | Local Postoperative Complications | 0 Participants |
| Healthy: L+E Mandibular Anesthesia | Local Postoperative Complications | 0 Participants |
p-value: <0.05Chi-squared
Secondary
Onset of Intraoral Local Anesthesia
Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection
Time frame: Up to 10 minutes, until subjective feeling of soft tissue numbnes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Onset of Intraoral Local Anesthesia | 1.76 minutes | Standard Deviation 0.87 |
| Diabetics: L+C Mandibular Anesthesia | Onset of Intraoral Local Anesthesia | 5.27 minutes | Standard Deviation 2.12 |
| Diabetics: L+E Maxillary Anesthesia | Onset of Intraoral Local Anesthesia | 2.16 minutes | Standard Deviation 1.08 |
| Diabetics: L+E Mandibular Anesthesia | Onset of Intraoral Local Anesthesia | 5.45 minutes | Standard Deviation 2.64 |
| Healthy: L+C Maxillary Anesthesia | Onset of Intraoral Local Anesthesia | 2.77 minutes | Standard Deviation 1.11 |
| Healthy: L+C Mandibular Anesthesia | Onset of Intraoral Local Anesthesia | 4.59 minutes | Standard Deviation 2.58 |
| Healthy: L+E Maxillary Anesthesia | Onset of Intraoral Local Anesthesia | 2.83 minutes | Standard Deviation 0.83 |
| Healthy: L+E Mandibular Anesthesia | Onset of Intraoral Local Anesthesia | 6.36 minutes | Standard Deviation 2.3 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Postoperative Analgesia
Number of participants who experienced postoperative pain, VAS, NRS
Time frame: up to 24 hours after tooth extraction
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Postoperative Analgesia | 11 Participants |
| Diabetics: L+C Mandibular Anesthesia | Postoperative Analgesia | 15 Participants |
| Diabetics: L+E Maxillary Anesthesia | Postoperative Analgesia | 13 Participants |
| Diabetics: L+E Mandibular Anesthesia | Postoperative Analgesia | 14 Participants |
| Healthy: L+C Maxillary Anesthesia | Postoperative Analgesia | 5 Participants |
| Healthy: L+C Mandibular Anesthesia | Postoperative Analgesia | 14 Participants |
| Healthy: L+E Maxillary Anesthesia | Postoperative Analgesia | 10 Participants |
| Healthy: L+E Mandibular Anesthesia | Postoperative Analgesia | 12 Participants |
p-value: <0.05Chi-squared
Secondary
Width of Anesthetic Field After Maxillary Infiltration Anesthesia
Soft tissue numbness area determined by pin-prick test after maxillary infiltration anesthesia. Not tested for mandibular ablock anesthesia.
Time frame: Up to 10 minutes after injection of local anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Width of Anesthetic Field After Maxillary Infiltration Anesthesia | 27.07 milimeters | Standard Deviation 1.06 |
| Diabetics: L+C Mandibular Anesthesia | Width of Anesthetic Field After Maxillary Infiltration Anesthesia | NA milimeters | — |
| Diabetics: L+E Maxillary Anesthesia | Width of Anesthetic Field After Maxillary Infiltration Anesthesia | 35.19 milimeters | Standard Deviation 1.67 |
| Diabetics: L+E Mandibular Anesthesia | Width of Anesthetic Field After Maxillary Infiltration Anesthesia | NA milimeters | — |
| Healthy: L+C Maxillary Anesthesia | Width of Anesthetic Field After Maxillary Infiltration Anesthesia | 23.81 milimeters | Standard Deviation 1.07 |
| Healthy: L+C Mandibular Anesthesia | Width of Anesthetic Field After Maxillary Infiltration Anesthesia | NA milimeters | — |
| Healthy: L+E Maxillary Anesthesia | Width of Anesthetic Field After Maxillary Infiltration Anesthesia | 24.52 milimeters | Standard Deviation 0.95 |
| Healthy: L+E Mandibular Anesthesia | Width of Anesthetic Field After Maxillary Infiltration Anesthesia | NA milimeters | — |
p-value: <0.05Wilcoxon (Mann-Whitney)