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

NCT04115904 | Unknown Phase 2 DMC

• 1 other identifier: 2019
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Pain intensity measure with general pain scale

  Each patient will recall a week to evaluate post operative pain

  a week

Study Arms (2)

Post-endodontic Pain after a RCT

EXPERIMENTAL

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

Acute pain

EXPERIMENTAL

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

Interventions

Ibuprofen for post operative pain PROCEDURE

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).

Also known as: Endodontic therapy

Acute pain; Post-endodontic Pain after a RCT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Patients from 18-65 years, both: male , fenale
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (4)

Jorge Paredes Vieyra

Tijuana, Baja Califronia, 22000, Mexico

Location

Jorge Paredes Vieyra

Tijuana, Estado de Baja California, 22000, Mexico

Location

Jose Clemente Orozco

Tijuana, Estado de Baja California, 22000, Mexico

Location

Jose Clemente

Tijuana, Estado de Baja California, 22000, Mexico

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen; Dental Implantation, Endosseous, Endodontic

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Endodontics; Dentistry; Prosthodontics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: compare Incidence of acute painafter single-visit ortwo-visits treatment of teeth with necrotic pulp
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jorge Paredes Vieyra DDS, MsC, PhD

Model Details: 110 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

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: February 8, 2018
• Primary Completion: September 29, 2018
• Study Completion: September 28, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Acute pain rate
• Access Criteria: Evaluate the acute pain rate

Locations

ME (4)