Acute Pain Rate of Single Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulps (Acute pain)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Ibuprofen for post operative 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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • BC
    • Tijuana, BC, Mexico, 22000
      • Jose Clemente
    • Tijuana, BC, Mexico, 22000
      • Jose Clemente Orozco
  • Baja California
    • Tijuana, Baja California, Mexico, 22000
      • Jorge Paredes Vieyra
  • Baja Califronia
    • Tijuana, Baja Califronia, Mexico, 22000
      • Jorge Paredes Vieyra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post-endodontic Pain after a RCT; Ibuprofen for Post operative pain. Take 400 mg takena week after. Incidence of flare ups after a single vsmultiple visits root canal treatments.	Procedure: Ibuprofen for post operative pain; All treatment sessions were approximately 45 minutes in length to allow for acceptable time for completionof treatment and retreatment in one or two visits. Allthe clinical procedures were performed by the author.Following local anesthesia with 2% lidocaine with1:100,000 epinephrine (Septodont Saint-Maur desFossés, France) and rubber dam isolation the toothwas disinfected with 5.25% NaOCl (Ultra bleach,Bentonville, AR, USA).; Other Names: Endodontic therapy
Experimental: Acute pain; Acetaminophen 325 mg for Acute pain. Taken secondday after. Incidence of Post operative pain after rootcanal treatment in one vs two visits	Procedure: Ibuprofen for post operative pain; All treatment sessions were approximately 45 minutes in length to allow for acceptable time for completionof treatment and retreatment in one or two visits. Allthe clinical procedures were performed by the author.Following local anesthesia with 2% lidocaine with1:100,000 epinephrine (Septodont Saint-Maur desFossés, France) and rubber dam isolation the toothwas disinfected with 5.25% NaOCl (Ultra bleach,Bentonville, AR, USA).; Other Names: Endodontic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity measure with general pain scale	Each patient will recall a week to evaluate post operative pain	a week

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Baja California

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): September 29, 2018
• Study Completion (Anticipated): September 28, 2019

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Acute Pain; Dental Pulp Necrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 2019 (Chief Medical Office (CMO) Alberta Health Services)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Each participant will be evaluated a week after the treatment
• IPD Sharing Time Frame: Acute pain rate
• IPD Sharing Access Criteria: Evaluate the acute pain rate
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No