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

NCT02371759 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2017-05-03

Study results available
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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.

Conditions

Interventions

DRUG

L+C maxillary anesthesia

Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)

DRUG

L+C mandibular anesthesia

Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)

DRUG

L+E maxillary anesthesia

Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)

DRUG

L+E mandibular anesthesia

Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)

Sponsors & Collaborators

  • University of Belgrade

    lead OTHER

Principal Investigators

  • Dragica DM Stojic, DDS, PhD · School of Dental Medicine, University of Belgrade

  • Bozidar M Brkovic, DDS, PhD · School of Dental Medicine, University of Belgrade

  • Marija S Milic, DDS · School of Dental Medicine, University of Belgrade

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Serbia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371759 on ClinicalTrials.gov