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

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ClinicalTrials.gov Identifier: NCT02815189
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Jorge Paredes Vieyra, 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.


Condition or disease Intervention/treatment Phase
Pain Procedure: Ibuprofen for post operative pain Drug: Acetaminophen 325 mg for Flare up Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : February 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: 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).
Other Name: Endodontic therapy

Drug: Acetaminophen 325 mg for Flare up
Each patient will be evaluated a week after completion the clinical procedures.
Other Name: Endodontic procedures

Experimental: 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.
Procedure: 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).
Other Name: Endodontic therapy

Drug: Acetaminophen 325 mg for Flare up
Each patient will be evaluated a week after completion the clinical procedures.
Other Name: Endodontic procedures




Primary Outcome Measures :
  1. Pain intensity measure with general pain scale [ Time Frame: a week ]
    Each patient will recall a week to evaluate post operative pain



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815189


Sponsors and Collaborators
Universidad Autonoma de Baja California
Investigators
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Study Chair: Miguel O Millan, PhD Mexico: Secretaria de Salud

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Responsible Party: Jorge Paredes Vieyra, DDS, MsC, PhD, Universidad Autonoma de Baja California
ClinicalTrials.gov Identifier: NCT02815189    
Other Study ID Numbers: 52016
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Each participant will be evaluated a week after the treatment.
Keywords provided by Jorge Paredes Vieyra, Universidad Autonoma de Baja California:
pain
Additional relevant MeSH terms:
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Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action