Incidence of Post-operative Pain After Single-visit Versus Two-visit Treatment
1 other identifier
interventional
110
0 countries
N/A
Brief Summary
Aim :to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Feb 2015
Longer than P75 for not_applicable postoperative-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2017
CompletedFirst Submitted
Initial submission to the registry
April 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedApril 19, 2017
April 1, 2017
2 years
April 14, 2017
April 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative pain in one visit
Pain intensity measure with general pain scale Each patient will recall a week to evaluate post operative pain
one week
Study Arms (2)
Post operative Pain in one visit RCT
EXPERIMENTALOne visit RCT Ibuprofen for Post operative pain. Take 400 mg every 6 hours, a week after.
Post operative pain in two-visits RCT
EXPERIMENTALTwo visits RCT Ibuprofen for Post operative pain. Take 400 mg every 6-8 hours, a week after.
Interventions
Root canal treatment in one vist
Root canal treatment in Two visits
Eligibility Criteria
You may qualify if:
- The aims and requirements of the study were freely accepted;
- Treatment was limited to patients in good health;
- All teeth had nonvital pulps and apical periodontitis, with or without a sinus tract;
- A negative response to hot and cold pulp sensitivity tests;
- Presence of sufficient coronal tooth structure for rubber dam isolation;
- No prior endodontic treatment on the involved tooth
- No analgesics or antibiotics were used five days before the clinical procedures began.
You may not qualify if:
- Patients who did not provide authorization for participation;
- Patients who were younger than 16 years old;
- Patients who were pregnant;
- Patients who were diabetic;
- Patients with a positive history of antibiotic use within the past month;
- Patients whose tooth had been previously accessed or endodontically treated;
- Teeth with root resorption,
- Immature/open apex, or a root canal in which patency of the apical foramen could not be established were all excluded from the study. Teeth with periodontal pockets deeper than 4 mm also were excluded of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.
PMID: 22892729BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Miguel O Osuna, DDS
SECRETARIA DE SALUD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- To compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis. Each participant received a root canal treatment (RTC)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- D.D.D., MsC, PhD
Study Record Dates
First Submitted
April 14, 2017
First Posted
April 19, 2017
Study Start
February 2, 2015
Primary Completion
February 2, 2017
Study Completion
February 26, 2017
Last Updated
April 19, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share
Each participant will be evaluated a week after the treatment.