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Clinical Trials/NCT04115904
NCT04115904
Unknown
Phase 2

Acute Pain Rate of Single Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulp and Apical Periodontitis: A Multicenter Clinical Trial

Universidad Autonoma de Baja California3 sites in 1 country90 target enrollmentFebruary 8, 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Universidad Autonoma de Baja California
Enrollment
90
Locations
3
Primary Endpoint
Pain intensity measure with general pain scale
Last Updated
6 years ago

Overview

Brief Summary

Aim to compare acute pain rate after single-visit ortwo-visits treatment of teeth with necrotic pulp and apical periodontitis .90 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex.Working length was established with EAL and confirmed radiographically. Flex-R files were used to complete canal preparation. Level ofdiscomfort were recorded and cases with acute postoperative pain.

Detailed Description

90 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex.Working length was established with EAL and confirmed radiographically. M4system with Flex-R files were used to complete canal preparation. Level ofdiscomfort were recorded and cases with severe postoperative pain and/orswelling were classified as acute pain.

Registry
clinicaltrials.gov
Start Date
February 8, 2018
End Date
September 28, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad Autonoma de Baja California
Responsible Party
Principal Investigator
Principal Investigator

Jorge Paredes Vieyra

Dr. Jorge Paredes Vieyra DDS, MsC, PhD

Universidad Autonoma de Baja California

Eligibility Criteria

Inclusion Criteria

  • a) Radiographic evidence of apical periodontitis (minimum size ≥2.0mm x 2.0 mm) and a diagnosis of pulpal necrosis confirmed by negativeresponse to hot and cold tests and b) Need for retreatment. Thermal pulptesting was performed by the author, and radiographic interpretation wasverified by one certified oral surgeon

Exclusion Criteria

  • patients without inclusion requirements or failure to obtain patient ́sauthorization. Patients, were excluded if they were younger than 18 yearsold, pregnant, had a positive history of antibiotic use within the past month,suffered from diabetes, or other systemic diseases. Teeth with periodontalpockets deeper than 4 mm also were excluded of the study

Outcomes

Primary Outcomes

Pain intensity measure with general pain scale

Time Frame: a week

Each patient will recall a week to evaluate post operative pain

Study Sites (3)

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