NCT02371759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus

Timeline
Completed

Started Jun 2013

Typical duration for phase_3 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 3, 2017

Completed
Last Updated

May 3, 2017

Status Verified

March 1, 2017

Enrollment Period

2.6 years

First QC Date

February 4, 2015

Results QC Date

December 26, 2016

Last Update Submit

March 22, 2017

Conditions

Diabetes MellitusLocal Anesthesia

Outcome Measures

Primary Outcomes (21)

  • 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 Outcomes (4)

  • Onset of Intraoral Local Anesthesia

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

  • Width of Anesthetic Field After Maxillary Infiltration Anesthesia

    Up to 10 minutes after injection of local anesthesia

  • Postoperative Analgesia

    up to 24 hours after tooth extraction

  • Local Postoperative Complications

    24 hours, 7 days

Study Arms (8)

Diabetics: L+C maxillary anesthesia

EXPERIMENTAL

Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia

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

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

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

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

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

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

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

Drug: L+E mandibular anesthesia

Interventions

L+C maxillary anesthesiaDRUG

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

Diabetics: L+C maxillary anesthesiaHealthy: L+C maxillary anesthesia
L+C mandibular anesthesiaDRUG

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

Diabetics: L+C mandibular anesthesiaHealthy: L+C mandibular anesthesia
L+E maxillary anesthesiaDRUG

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

Diabetics: L+E maxillary anesthesiaHealthy: L+E maxillary anesthesia
L+E mandibular anesthesiaDRUG

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

Diabetics: L+E mandibular anesthesiaHealthy: L+E mandibular anesthesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
DDS PhD Professor Dragica Stojic, DDS PhD Professor Bozidar Brkovic, DDS PhD Marija Milic
Organization
University of Belgrade, Faculty of Dental Medicine
brkovic73@yahoo.com
+ 381 11 2685 280

Study Officials

  • Dragica DM Stojic, DDS, PhD

    School of Dental Medicine, University of Belgrade

    PRINCIPAL INVESTIGATOR

  • Bozidar M Brkovic, DDS, PhD

    School of Dental Medicine, University of Belgrade

    PRINCIPAL INVESTIGATOR

  • Marija S Milic, DDS

    School of Dental Medicine, University of Belgrade

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, DDS, MSc, PhD

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 26, 2015

Study Start

June 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 3, 2017

Results First Posted

May 3, 2017

Record last verified: 2017-03

Locations

SE(1)