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

NCT ID: NCT04115904

Last Updated: 2019-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-08

Study Completion Date

2019-09-28

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
compare Incidence of acute painafter single-visit ortwo-visits treatment of teeth with necrotic pulp

Study Groups

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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.

Group Type EXPERIMENTAL

Ibuprofen for post operative pain

Intervention Type 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).

Acute pain

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

Group Type EXPERIMENTAL

Ibuprofen for post operative pain

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Other Intervention Names

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Endodontic therapy

Eligibility Criteria

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Inclusion Criteria

\-

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Autonoma de Baja California

OTHER

Sponsor Role lead

Responsible Party

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Jorge Paredes Vieyra

Dr. Jorge Paredes Vieyra DDS, MsC, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jorge Paredes Vieyra

Tijuana, Baja Califronia, Mexico

Site Status

Jorge Paredes Vieyra

Tijuana, Estado de Baja California, Mexico

Site Status

Jose Clemente Orozco

Tijuana, Estado de Baja California, Mexico

Site Status

Jose Clemente

Tijuana, Estado de Baja California, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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2019

Identifier Type: -

Identifier Source: org_study_id

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