Diabetes MellitusPhase 3LCIOADMT2NCT02371759

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

A Phase 3 study testing L+C maxillary anesthesia, L+C mandibular anesthesia and L+E maxillary anesthesia in people with Diabetes Mellitus and Local Anesthesia, run by University of Belgrade at 1 site in Serbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus, Local Anesthesia
What is being tested?: L+C maxillary anesthesia, L+C mandibular anesthesia and L+E maxillary anesthesia
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 256 participants
Where: 1 siteSerbia
Study dates: Jun 2013to Jan 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Serbia1 site

School of Dental Medicine, University of Belgrade
Belgrade, 11000

Other trials in Serbia

About this study

Official title: Efficacy and Safety of Intraoral Local Anesthesia by Lidocaine + Clonidine in Patients With Diabetes Mellitus Type 2

Read the 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.

Conditions: Diabetes Mellitus, Local Anesthesia
Being tested: L+C maxillary anesthesia, L+C mandibular anesthesia, L+E maxillary anesthesia, L+E mandibular anesthesia
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

L+C maxillary anesthesiaDrug
Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
L+C mandibular anesthesiaDrug
Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
L+E maxillary anesthesiaDrug
Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
L+E mandibular anesthesiaDrug
Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)

Study groups in NCT02371759
Study group	Role	What they receive
Diabetics: L+C maxillary anesthesia	Experimental	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia Receives: Drug: L+C maxillary anesthesia
Diabetics: L+C mandibular anesthesia	Experimental	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia Receives: Drug: L+C mandibular anesthesia
Diabetics: L+E maxillary anesthesia	Active comparator	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia Receives: Drug: L+E maxillary anesthesia
Diabetics: L+E mandibular anesthesia	Active comparator	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia Receives: Drug: L+E mandibular anesthesia
Healthy: L+C maxillary anesthesia	Experimental	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia Receives: Drug: L+C maxillary anesthesia
Healthy: L+C mandibular anesthesia	Experimental	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia Receives: Drug: L+C mandibular anesthesia
Healthy: L+E maxillary anesthesia	Active comparator	Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia Receives: Drug: L+E maxillary anesthesia
Healthy: L+E mandibular anesthesia	Active comparator	Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia Receives: Drug: L+E mandibular anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Intraoral Local Anesthesia
Time until cessation in soft tissue numbness
Measured: Up to 6 hours after local anesthesia injection
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.
Measured: Up to 10 minutes after local anesthesia injection
Baseline Systolic Blood Pressure
Measured: Baseline, 0 minutes
Systolic Blood Pressure at 10 Minutes
Systolic blood pressure values 5 minutes after local anesthesia injection
Measured: 10th minute
Systolic Blood Pressure at 15 Minutes
Systolic blood pressure values 10 minutes after local anesthesia injection
Measured: 15th minute
Systolic Blood Pressure at 20 Minutes
Systolic blood pressure values 15 minutes after local anesthesia injection
Measured: 20th minute
Systolic Blood Pressure at 35 Minutes
Systolic blood pressure values 30 minutes after local anesthesia injection
Measured: 35th minute
Baseline Diastolic Blood Pressure
Measured: baseline, 0 minutes
Diastolic Blood Pressure at 10 Minutes
Diastolic blood pressure values 5 minutes after local anesthesia injection
Measured: 10th minute
Diastolic Blood Pressure at 15 Minutes
Diastolic blood pressure values 10 minutes after local anesthesia injection
Measured: 15th minute
Diastolic Blood Pressure at 20 Minutes
Diastolic blood pressure values 15 minutes after local anesthesia injection
Measured: 20th minute
Diastolic Blood Pressure at 35 Minutes
Diastolic blood pressure values 30 minutes after local anesthesia injection
Measured: 35th minute
Baseline Values of Heart Rate
Measured: baseline, 0 minutes
Heart Rate at 10 Minutes
Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Measured: 10th minute
Heart Rate at 15 Minutes
Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Measured: 15th minute
Heart Rate at 20 Minutes
Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
Measured: 20th minute
Ceart Rate at 35 Minutes
Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement
Measured: 35th minute
Baseline Electrocardiogram
Measured: baseline, 0 minutes
Electrocardiogram at 10 Minutes
ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Measured: 10th minute
Electrocardiogram at 15 Minutes
ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Measured: 15th minute
Electrocardiogram at 20 Minutes
ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
Measured: 20th minute

Secondary outcomes (4)

Onset of Intraoral Local Anesthesia
Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection
Measured: Up to 10 minutes, until subjective feeling of soft tissue numbnes
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.
Measured: Up to 10 minutes after injection of local anesthesia
Postoperative Analgesia
Number of participants who experienced postoperative pain, VAS, NRS
Measured: up to 24 hours after tooth extraction
Local Postoperative Complications
Postoperative paresthesia by clinical examination
Measured: 24 hours, 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jan 2016

First posted26 Feb 2015 (estimated)
Study startJun 2013
Primary completionJan 2016
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 256 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02371759
Sponsor's protocol ID: UBelgrade 534/2
Other IDs: 175021
Acronym: LCIOADMT2
Status last verified: Mar 2017
First submitted: 4 Feb 2015
Last updated: 3 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Intraoral Local Anesthesia by Lidocaine + Clonidine in Patients With Diabetes Mellitus Type 2
ClinicalTrials.gov ID: NCT02371759
Acronym / sponsor ID: LCIOADMT2 / UBelgrade 534/2
Conditions: Diabetes Mellitus, Local Anesthesia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 256 participants (actual)
Lead sponsor: University of BelgradeUniversity, hospital or other
Study start: Jun 2013
Primary completion: Jan 2016 (actual)
Study completion: Jan 2016 (actual)
First posted: 26 Feb 2015 (estimated)
Results: Posted 3 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Diabetics: L+C maxillary anesthesia	Experimental	Drug: L+C maxillary anesthesiaSingle dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
Diabetics: L+C mandibular anesthesia	Experimental	Drug: L+C mandibular anesthesiaSingle dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
Diabetics: L+E maxillary anesthesia	Active comparator	Drug: L+E maxillary anesthesiaSingle dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
Diabetics: L+E mandibular anesthesia	Active comparator	Drug: L+E mandibular anesthesiaSingle dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
Healthy: L+C maxillary anesthesia	Experimental	Drug: L+C maxillary anesthesiaSingle dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
Healthy: L+C mandibular anesthesia	Experimental	Drug: L+C mandibular anesthesiaSingle dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
Healthy: L+E maxillary anesthesia	Active comparator	Drug: L+E maxillary anesthesiaSingle dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
Healthy: L+E mandibular anesthesia	Active comparator	Drug: L+E mandibular anesthesiaSingle dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

Pregnancy and lactation
Allergy to used drugs and food
Hepatic and/or renal failure
ASA IV patients
Tobacco smokers

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
L+C maxillary anesthesiaMaxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Drug	Diabetics: L+C maxillary anesthesia, Healthy: L+C maxillary anesthesia
L+C mandibular anesthesiaMandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)	Drug	Diabetics: L+C mandibular anesthesia, Healthy: L+C mandibular anesthesia
L+E maxillary anesthesiaMaxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Drug	Diabetics: L+E maxillary anesthesia, Healthy: L+E maxillary anesthesia
L+E mandibular anesthesiaMandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)	Drug	Diabetics: L+E mandibular anesthesia, Healthy: L+E mandibular anesthesia

Primary outcome

Duration of Intraoral Local Anesthesia
Time frame: Up to 6 hours after local anesthesia injection
Time until cessation in soft tissue numbness
Intensity of Intraoral Local Anesthesia
Time frame: 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
Time frame: Baseline, 0 minutes
Systolic Blood Pressure at 10 Minutes
Time frame: 10th minute
Systolic blood pressure values 5 minutes after local anesthesia injection
Systolic Blood Pressure at 15 Minutes
Time frame: 15th minute
Systolic blood pressure values 10 minutes after local anesthesia injection
Systolic Blood Pressure at 20 Minutes
Time frame: 20th minute
Systolic blood pressure values 15 minutes after local anesthesia injection
Systolic Blood Pressure at 35 Minutes
Time frame: 35th minute
Systolic blood pressure values 30 minutes after local anesthesia injection
Baseline Diastolic Blood Pressure
Time frame: baseline, 0 minutes
Diastolic Blood Pressure at 10 Minutes
Time frame: 10th minute
Diastolic blood pressure values 5 minutes after local anesthesia injection
Diastolic Blood Pressure at 15 Minutes
Time frame: 15th minute
Diastolic blood pressure values 10 minutes after local anesthesia injection
Diastolic Blood Pressure at 20 Minutes
Time frame: 20th minute
Diastolic blood pressure values 15 minutes after local anesthesia injection
Diastolic Blood Pressure at 35 Minutes
Time frame: 35th minute
Diastolic blood pressure values 30 minutes after local anesthesia injection
Baseline Values of Heart Rate
Time frame: baseline, 0 minutes
Heart Rate at 10 Minutes
Time frame: 10th minute
Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Heart Rate at 15 Minutes
Time frame: 15th minute
Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Heart Rate at 20 Minutes
Time frame: 20th minute
Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement
Ceart Rate at 35 Minutes
Time frame: 35th minute
Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement
Baseline Electrocardiogram
Time frame: baseline, 0 minutes
Electrocardiogram at 10 Minutes
Time frame: 10th minute
ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement
Electrocardiogram at 15 Minutes
Time frame: 15th minute
ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement
Electrocardiogram at 20 Minutes
Time frame: 20th minute
ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement

4 secondary outcomes

Onset of Intraoral Local Anesthesia
Time frame: Up to 10 minutes, until subjective feeling of soft tissue numbnes
Width of Anesthetic Field After Maxillary Infiltration Anesthesia
Time frame: Up to 10 minutes after injection of local anesthesia
Postoperative Analgesia
Time frame: up to 24 hours after tooth extraction
Local Postoperative Complications
Time frame: 24 hours, 7 days

Results and safety

Results posted to the registry on 3 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diabetics: L+C Maxillary Anesthesia	32	29
Diabetics: L+C Mandibular Anesthesia	31	30
Diabetics: L+E Maxillary Anesthesia	33	32
Diabetics: L+E Mandibular Anesthesia	31	31
Healthy: L+C Maxillary Anesthesia	27	24
Healthy: L+C Mandibular Anesthesia	26	25
Healthy: L+E Maxillary Anesthesia	25	25
Healthy: L+E Mandibular Anesthesia	28	24

Primary outcome: Duration of Intraoral Local Anesthesia

Time frame: Up to 6 hours after local anesthesia injection. Mean (Standard Deviation). Unit: minutes

Measure	Diabetics: L+C Maxillary Anesthesia n = 29	Diabetics: L+C Mandibular Anesthesia n = 30	Diabetics: L+E Maxillary Anesthesia n = 32	Diabetics: L+E Mandibular Anesthesia n = 31	Healthy: L+C Maxillary Anesthesia n = 24	Healthy: L+C Mandibular Anesthesia n = 25	Healthy: L+E Maxillary Anesthesia n = 25	Healthy: L+E Mandibular Anesthesia n = 24
Value	132.48 (91.86)	173.27 (70.44)	182.09 (57.86)	195.35 (68.99)	108.82 (27.76)	155.59 (60.75)	114.74 (39.72)	172.91 (68.93)

Diabetics: L+C Maxillary Anesthesia vs Diabetics: L+C Mandibular Anesthesia vs Diabetics: L+E Maxillary Anesthesia vs Diabetics: L+E Mandibular Anesthesia vs Healthy: L+C Maxillary Anesthesia vs Healthy: L+C Mandibular Anesthesia vs Healthy: L+E Maxillary Anesthesia vs Healthy: L+E Mandibular Anesthesia: p <0.05, Wilcoxon (Mann-Whitney)

Primary outcome: Intensity of Intraoral Local Anesthesia

Time frame: Up to 10 minutes after local anesthesia injection. Count of participants. Unit: Participants

Measure	Diabetics: L+C Maxillary Anesthesia n = 29	Diabetics: L+C Mandibular Anesthesia n = 30	Diabetics: L+E Maxillary Anesthesia n = 32	Diabetics: L+E Mandibular Anesthesia n = 31	Healthy: L+C Maxillary Anesthesia n = 24	Healthy: L+C Mandibular Anesthesia n = 25	Healthy: L+E Maxillary Anesthesia n = 25	Healthy: L+E Mandibular Anesthesia n = 24
Value	2	2	1	8	2	1	4	6

Diabetics: L+C Maxillary Anesthesia vs Diabetics: L+C Mandibular Anesthesia vs Diabetics: L+E Maxillary Anesthesia vs Diabetics: L+E Mandibular Anesthesia vs Healthy: L+C Maxillary Anesthesia vs Healthy: L+C Mandibular Anesthesia vs Healthy: L+E Maxillary Anesthesia vs Healthy: L+E Mandibular Anesthesia: p <0.05, Chi-squared

Primary outcome: Baseline Systolic Blood Pressure

Time frame: Baseline, 0 minutes. Mean (Standard Deviation). Unit: milimeters of Hg

Measure	Diabetics: L+C Maxillary Anesthesia n = 29	Diabetics: L+C Mandibular Anesthesia n = 30	Diabetics: L+E Maxillary Anesthesia n = 32	Diabetics: L+E Mandibular Anesthesia n = 31	Healthy: L+C Maxillary Anesthesia n = 24	Healthy: L+C Mandibular Anesthesia n = 25	Healthy: L+E Maxillary Anesthesia n = 25	Healthy: L+E Mandibular Anesthesia n = 24
Value	135.2759 (16.69665611)	137.7333 (18.43335308)	134.8125 (18.66934265)	134.4667 (17.69119729)	124.0455 (11.07325079)	128.1818 (15.49388931)	125 (11.11918898)	126.5909 (18.82322642)

Primary outcome: Systolic Blood Pressure at 10 Minutes

Time frame: 10th minute. Mean (Standard Deviation). Unit: milimeters of Hg

Measure	Diabetics: L+C Maxillary Anesthesia n = 29	Diabetics: L+C Mandibular Anesthesia n = 30	Diabetics: L+E Maxillary Anesthesia n = 32	Diabetics: L+E Mandibular Anesthesia n = 31	Healthy: L+C Maxillary Anesthesia n = 24	Healthy: L+C Mandibular Anesthesia n = 25	Healthy: L+E Maxillary Anesthesia n = 25	Healthy: L+E Mandibular Anesthesia n = 24
Value	130.3793 (18.81377496)	136.8333 (14.27098173)	137.4375 (19.73033934)	132.6 (20.45858857)	120.8182 (13.58092627)	122.5909 (14.59503859)	125.8261 (13.75979708)	125,4091 (12.71541656)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetics: L+C Maxillary Anesthesia	0 of 29 (0%)	0 of 29 (0%)	Not reported
Diabetics: L+C Mandibular Anesthesia	0 of 30 (0%)	0 of 30 (0%)	Not reported
Diabetics: L+E Maxillary Anesthesia	0 of 32 (0%)	0 of 32 (0%)	Not reported
Diabetics: L+E Mandibular Anesthesia	0 of 31 (0%)	0 of 31 (0%)	Not reported
Healthy: L+C Maxillary Anesthesia	0 of 24 (0%)	0 of 24 (0%)	Not reported
Healthy: L+C Mandibular Anesthesia	0 of 25 (0%)	0 of 25 (0%)	Not reported
Healthy: L+E Maxillary Anesthesia	0 of 25 (0%)	0 of 25 (0%)	Not reported
Healthy: L+E Mandibular Anesthesia	0 of 24 (0%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dragica DM Stojic, DDS, PhD principal investigator

School of Dental Medicine, University of Belgrade

Bozidar M Brkovic, DDS, PhD principal investigator

School of Dental Medicine, University of Belgrade

Marija S Milic, DDS principal investigator

School of Dental Medicine, University of Belgrade

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Intraoral Local Anesthesia (time frame: Up to 6 hours after local anesthesia injection). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02371759.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.