Phase 3 N=233 Randomized Quadruple-blind Supportive Care

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

Diabetes Mellitus · Local Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT02371759 ↗

Enrolled (actual)

233

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Duration of Intraoral Local Anesthesia — 132.48; 173.27; 182.09; 195.35 minutes — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: L+C maxillary anesthesia (Drug); L+C mandibular anesthesia (Drug); L+E maxillary anesthesia (Drug); L+E mandibular anesthesia (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Belgrade
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Duration of Intraoral Local Anesthesia	132.48; 173.27; 182.09; 195.35; 108.82; 155.59	<0.05 sig
PRIMARY Intensity of Intraoral Local Anesthesia	2; 2; 1; 8; 2; 1	<0.05 sig
PRIMARY Baseline Systolic Blood Pressure	135.2759; 137.7333; 134.8125; 134.4667; 124.0455; 128.1818	—
PRIMARY Systolic Blood Pressure at 10 Minutes	130.3793; 136.8333; 137.4375; 132.6; 120.8182; 122.5909	—
PRIMARY Systolic Blood Pressure at 15 Minutes	133.5862; 133.4667; 137.4688; 132.0667; 114.4545; 116.9091	—
PRIMARY Systolic Blood Pressure at 20 Minutes	130.2414; 131.3333; 132.4063; 133.2333; 108.8182; 120.8636	—
PRIMARY Systolic Blood Pressure at 35 Minutes	127.2759; 130.3; 132.5625; 132.7; 116.3636; 120.1364	—
PRIMARY Baseline Diastolic Blood Pressure	74.1379; 81.7667; 75.25; 79.2; 73.1364; 80.9545	—
PRIMARY Diastolic Blood Pressure at 10 Minutes	74.0345; 75.3667; 75.6875; 79.1; 69.7273; 75.0909	—
PRIMARY Diastolic Blood Pressure at 15 Minutes	72.6897; 74.8; 74.8125; 80.0333; 69.3636; 72.5	—
PRIMARY Diastolic Blood Pressure at 20 Minutes	71.6897; 74.1667; 74.1563; 80.8333; 69.4545; 75.9545	—
PRIMARY Diastolic Blood Pressure at 35 Minutes	70.1379; 74.3667; 73.2813; 75.9; 69.1364; 77.0455	—
PRIMARY Baseline Values of Heart Rate	75.0345; 80.7727; 78.3438; 84.2581; 76.4545; 73.0333	—
PRIMARY Heart Rate at 10 Minutes	75.3448; 81.7727; 83.3125; 88.5806; 74.0455; 73.0667	—
PRIMARY Heart Rate at 15 Minutes	73.0345; 77.4545; 83.4688; 86.8387; 74.5; 73.4333	—
PRIMARY Heart Rate at 20 Minutes	72.2414; 80.2273; 81.3125; 86.1935; 73.6818; 71.8667	—
PRIMARY Ceart Rate at 35 Minutes	72.1034; 80.8182; 80.0938; 85.3871; 71.3636; 73.4333	—
PRIMARY Baseline Electrocardiogram	0; 0; 0; 0; 0; 0	<0.05 sig
PRIMARY Electrocardiogram at 10 Minutes	0; 0; 0; 0; 0; 0	<0.05 sig
PRIMARY Electrocardiogram at 15 Minutes	0; 0; 0; 0; 0; 0	<0.05 sig
PRIMARY Electrocardiogram at 20 Minutes	0; 0; 0; 0; 0; 0	<0.05 sig
SECONDARY Onset of Intraoral Local Anesthesia	1.76; 5.27; 2.16; 5.45; 2.77; 4.59	<0.05 sig
SECONDARY Width of Anesthetic Field After Maxillary Infiltration Anesthesia	27.07; NA; 35.19; NA; 23.81; NA	<0.05 sig
SECONDARY Postoperative Analgesia	11; 15; 13; 14; 5; 14	<0.05 sig
SECONDARY Local Postoperative Complications	1; 1; 6; 4; 0; 0	<0.05 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02371759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.