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

Phase 2

Completed

• Conditions: Pain
• Interventions: Procedure: Ibuprofen for post operative pain; Drug: Acetaminophen 325 mg for Flare up

• Registration Number: NCT02815189
• Lead Sponsor: Universidad Autonoma de Baja California

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2016-02
• Study Completion: 2016-05
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post operative Pain after a RCT	Ibuprofen for post operative pain	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.
Post operative Pain after a RCT	Acetaminophen 325 mg for Flare up	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.
Flare up	Ibuprofen for post operative pain	Acetaminophen 325 mg for Flare Up. Taken second day after. Incidence of Post operative pain after root canal treatment in one vs two visits.
Flare up	Acetaminophen 325 mg for 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.

Primary Outcome Measures

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