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Clinical Trial Details

Trial ID: L5517
Source ID: NCT02371759
Associated Drug: L+C Maxillary Anesthesia
Title: Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2
Acronym: LCIOADMT2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02371759/results
Conditions: Diabetes Mellitus|Local Anesthesia
Interventions: DRUG: L+C maxillary anesthesia|DRUG: L+C mandibular anesthesia|DRUG: L+E maxillary anesthesia|DRUG: L+E mandibular anesthesia
Outcome Measures: Primary: Duration of Intraoral Local Anesthesia, Time until cessation in soft tissue numbness, 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., Up to 10 minutes after local anesthesia injection|Baseline Systolic Blood Pressure, Baseline, 0 minutes|Systolic Blood Pressure at 10 Minutes, Systolic blood pressure values 5 minutes after local anesthesia injection, 10th minute|Systolic Blood Pressure at 15 Minutes, Systolic blood pressure values 10 minutes after local anesthesia injection, 15th minute|Systolic Blood Pressure at 20 Minutes, Systolic blood pressure values 15 minutes after local anesthesia injection, 20th minute|Systolic Blood Pressure at 35 Minutes, Systolic blood pressure values 30 minutes after local anesthesia injection, 35th minute|Baseline Diastolic Blood Pressure, baseline, 0 minutes|Diastolic Blood Pressure at 10 Minutes, Diastolic blood pressure values 5 minutes after local anesthesia injection, 10th minute|Diastolic Blood Pressure at 15 Minutes, Diastolic blood pressure values 10 minutes after local anesthesia injection, 15th minute|Diastolic Blood Pressure at 20 Minutes, Diastolic blood pressure values 15 minutes after local anesthesia injection, 20th minute|Diastolic Blood Pressure at 35 Minutes, Diastolic blood pressure values 30 minutes after local anesthesia injection, 35th minute|Baseline Values of Heart Rate, baseline, 0 minutes|Heart Rate at 10 Minutes, Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement, 10th minute|Heart Rate at 15 Minutes, Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement, 15th minute|Heart Rate at 20 Minutes, Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement, 20th minute|Ceart Rate at 35 Minutes, Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement, 35th minute|Baseline Electrocardiogram, baseline, 0 minutes|Electrocardiogram at 10 Minutes, ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement, 10th minute|Electrocardiogram at 15 Minutes, ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement, 15th minute|Electrocardiogram at 20 Minutes, ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement, 20th minute | Secondary: Onset of Intraoral Local Anesthesia, Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection, 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., Up to 10 minutes after injection of local anesthesia|Postoperative Analgesia, Number of participants who experienced postoperative pain, VAS, NRS, up to 24 hours after tooth extraction|Local Postoperative Complications, Postoperative paresthesia by clinical examination, 24 hours, 7 days
Sponsor/Collaborators: Sponsor: University of Belgrade
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 256
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2013-06
Completion Date: 2016-01
Results First Posted: 2017-05-03
Last Update Posted: 2017-05-03
Locations: School of Dental Medicine, University of Belgrade, Belgrade, 11000, Serbia
URL: https://clinicaltrials.gov/show/NCT02371759