Incidence of Flare-ups and Apical Healing After Single-visit or Two-visits Treatment.

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-05-31

Brief Summary

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Aim to compare Incidence of flare-ups and apical healing after single-visit or two-visits treatment of teeth with necrotic pulp and apical periodontitis after a two-year control period.

110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working length was established with EAL and confirmed radiographically. M4 system with Flex-R files were used to complete canal preparation. Level of discomfort were recorded and cases with severe postoperative pain and/or swelling were classified as flare-ups.

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Detailed Description

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110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working length was established with EAL and confirmed radiographically. M4 system with Flex-R files were used to complete canal preparation. Level of discomfort were recorded and cases with severe postoperative pain and/or swelling were classified as flare-ups.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Post operative Pain after a RCT

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

Group Type EXPERIMENTAL

Ibuprofen for post operative pain

Intervention Type PROCEDURE

All treatment sessions were approximately 50 minutes in length to allow for acceptable time for completion of treatment and retreatment in one or two visits. All the clinical procedures were performed by the author. Following local anesthesia with 2% lidocaine with 1:100,000 epinephrine (Septodont Saint-Maur des Fossés, France) and rubber dam isolation the tooth was disinfected with 5.25% NaOCl (Ultra bleach, Bentonville, AR, USA).

Acetaminophen 325 mg for Flare up

Intervention Type DRUG

Each patient will be evaluated a week after completion the clinical procedures.

Flare up

Acetaminophen 325 mg for Flare Up. Taken second day after. Incidence of Post operative pain after root canal treatment in one vs two visits.

Group Type EXPERIMENTAL

Ibuprofen for post operative pain

Intervention Type PROCEDURE

All treatment sessions were approximately 50 minutes in length to allow for acceptable time for completion of treatment and retreatment in one or two visits. All the clinical procedures were performed by the author. Following local anesthesia with 2% lidocaine with 1:100,000 epinephrine (Septodont Saint-Maur des Fossés, France) and rubber dam isolation the tooth was disinfected with 5.25% NaOCl (Ultra bleach, Bentonville, AR, USA).

Acetaminophen 325 mg for Flare up

Intervention Type DRUG

Each patient will be evaluated a week after completion the clinical procedures.

Interventions

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Ibuprofen for post operative pain

All treatment sessions were approximately 50 minutes in length to allow for acceptable time for completion of treatment and retreatment in one or two visits. All the clinical procedures were performed by the author. Following local anesthesia with 2% lidocaine with 1:100,000 epinephrine (Septodont Saint-Maur des Fossés, France) and rubber dam isolation the tooth was disinfected with 5.25% NaOCl (Ultra bleach, Bentonville, AR, USA).

Intervention Type PROCEDURE

Acetaminophen 325 mg for Flare up

Each patient will be evaluated a week after completion the clinical procedures.

Intervention Type DRUG

Other Intervention Names

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Endodontic therapy Endodontic procedures

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients without inclusion requirements or failure to obtain patient´s authorization. Patients, were excluded if they were younger than 18 years old, pregnant, had a positive history of antibiotic use within the past month, suffered from diabetes, or other systemic diseases. Teeth with periodontal pockets deeper than 4 mm also were excluded of the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes