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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Ibuprofen for post operative pain
Sponsored by
Universidad Autonoma de Baja California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jorge Paredes Vieyra
  • Jorge Paredes Vieyra
  • Jose Clemente Orozco
  • Jose Clemente

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Post-endodontic Pain after a RCT

Acute pain

Arm Description

Ibuprofen for Post operative pain. Take 400 mg takena week after. Incidence of flare ups after a single vsmultiple visits root canal treatments.

Acetaminophen 325 mg for Acute pain. Taken secondday after. Incidence of Post operative pain after rootcanal treatment in one vs two visits

Outcomes

Primary Outcome Measures

Pain intensity measure with general pain scale
Each patient will recall a week to evaluate post operative pain

Secondary Outcome Measures

Full Information

First Posted
October 2, 2019
Last Updated
October 3, 2019
Sponsor
Universidad Autonoma de Baja California
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1. Study Identification

Unique Protocol Identification Number
NCT04115904
Brief Title
Acute Pain Rate of Single Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulps
Acronym
Acute pain
Official Title
Acute Pain Rate of Single Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulp and Apical Periodontitis: A Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
September 29, 2018 (Actual)
Study Completion Date
September 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Baja California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Investigator
Masking Description
compare Incidence of acute painafter single-visit ortwo-visits treatment of teeth with necrotic pulp
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-endodontic Pain after a RCT
Arm Type
Experimental
Arm Description
Ibuprofen for Post operative pain. Take 400 mg takena week after. Incidence of flare ups after a single vsmultiple visits root canal treatments.
Arm Title
Acute pain
Arm Type
Experimental
Arm Description
Acetaminophen 325 mg for Acute pain. Taken secondday after. Incidence of Post operative pain after rootcanal treatment in one vs two visits
Intervention Type
Procedure
Intervention Name(s)
Ibuprofen for post operative pain
Other Intervention Name(s)
Endodontic therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain intensity measure with general pain scale
Description
Each patient will recall a week to evaluate post operative pain
Time Frame
a week

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Patients from 18-65 years, both: male , fenale
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Jorge Paredes Vieyra
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22000
Country
Mexico
Facility Name
Jorge Paredes Vieyra
City
Tijuana
State/Province
Baja Califronia
ZIP/Postal Code
22000
Country
Mexico
Facility Name
Jose Clemente Orozco
City
Tijuana
State/Province
BC
ZIP/Postal Code
22000
Country
Mexico
Facility Name
Jose Clemente
City
Tijuana
State/Province
BC
ZIP/Postal Code
22000
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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