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

Study Overview
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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.

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.

Official Title
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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. A Randomised Clinical Trial.

Conditions
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Pain

Intervention / Treatment
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* Procedure: Ibuprofen for post operative pain
* Drug: Acetaminophen 325 mg for Flare up


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post operative Pain after a RCT<br>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. | Procedure: Ibuprofen for post operative pain<br>* 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).<br>* Other names: Endodontic therapy;Drug: Acetaminophen 325 mg for Flare up<br>* Each patient will be evaluated a week after completion the clinical procedures.<br>* Other names: Endodontic procedures;|
| Experimental: Flare up<br>Acetaminophen 325 mg for Flare Up. Taken second day after. Incidence of Post operative pain after root canal treatment in one vs two visits. | Procedure: Ibuprofen for post operative pain<br>* 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).<br>* Other names: Endodontic therapy;Drug: Acetaminophen 325 mg for Flare up<br>* Each patient will be evaluated a week after completion the clinical procedures.<br>* Other names: Endodontic procedures;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain