CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Surgery with 2%Articaine first, then Surgery with 4% Articaine +1 moredrug
Likely dose
Surgery with 2%Articaine first, then Surgery with 4% Articainefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02457325
NCT02457325Phase 4Completed

Comparative Analysis Between 2% and Articaine Articaine 4%, Both With 1: 200,000 Epinephrine: Evaluation of Anesthetics Efficacy, Intraoperative Bleeding and Hemodynamic Parameters in Extraction of Lower Third Molars

University of Sao Paulo·interventional·Posted May 29, 2015·Updated Nov 24, 2020

In Brief

A Phase 4 clinical trial evaluating Surgery with 2%Articaine first, then Surgery with 4% Articaine and Surgery with 4%Articaine first, then Surgery with 2% Articaine for Impacted Third Molar Tooth and Adverse Reaction to Other Local Anesthetics. Completed, enrolled 50 participants.

Detailed Summary

The present clinical trial randomized compared the clinical efficacy of the local anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 2% or 4% (both with 1:200,000 adrenaline) in a double-blind, randomized and crossed manner.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 29, 2015
Enrollment StartJun 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.1 years ago

Interventions

Surgery with 2%Articaine first, then Surgery with 4% Articainedrug

First Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)

Surgery with 4%Articaine first, then Surgery with 2% Articainedrug

First Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)