Back to resultsIncidence of Post-operative Pain After Single-visit Versus Two-visit Treatment
Primary Purpose
Post-operative Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
One visit RCT
Post operative pain in two-visits RCT
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring Pain,, one-visit, two visits
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who did not meet inclusion requirements;
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Post operative Pain in one visit RCT
Post operative pain in two-visits RCT
Arm Description
One visit RCT Ibuprofen for Post operative pain. Take 400 mg every 6 hours, a week after.
Two visits RCT Ibuprofen for Post operative pain. Take 400 mg every 6-8 hours, a week after.
Outcomes
Primary Outcome Measures
Post-operative pain in one visit
Pain intensity measure with general pain scale Each patient will recall a week to evaluate post operative pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03120845
Brief Title
Incidence of Post-operative Pain After Single-visit Versus Two-visit Treatment
Official Title
Incidence of Post-operative Pain After Single-visit Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulp and Apical Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2, 2015 (undefined)
Primary Completion Date
February 2, 2017 (Actual)
Study Completion Date
February 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jorge Paredes Vieyra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
Methodology: All teeth of the one and two-visit group were asymptomatic (92) and symptomatic (18) with a diagnosis of pulp necrosis (RCT cases) determined by hot and cold sensitivity tests and radiographically all teeth showed a small and irregular radiolucency at the tooth apex. Working length was established with EAL and confirmed radiographically. Reciprocating files (VDW, Munich Germany) were used to complete root canal preparation. EDTA served as a lubricant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
Pain,, one-visit, two visits
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Ibuprofen for post operative pain. after RCT in one visit
Masking
Participant
Masking Description
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)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Post operative Pain in one visit RCT
Arm Type
Experimental
Arm Description
One visit RCT Ibuprofen for Post operative pain. Take 400 mg every 6 hours, a week after.
Arm Title
Post operative pain in two-visits RCT
Arm Type
Experimental
Arm Description
Two visits RCT Ibuprofen for Post operative pain. Take 400 mg every 6-8 hours, a week after.
Intervention Type
Procedure
Intervention Name(s)
One visit RCT
Other Intervention Name(s)
Endodontic therapy
Intervention Description
Root canal treatment in one vist
Intervention Type
Procedure
Intervention Name(s)
Post operative pain in two-visits RCT
Other Intervention Name(s)
Endodontic Therapy
Intervention Description
Root canal treatment in Two visits
Primary Outcome Measure Information:
Title
Post-operative pain in one visit
Description
Pain intensity measure with general pain scale Each patient will recall a week to evaluate post operative pain
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients who did not meet inclusion requirements;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel O Osuna, DDS
Organizational Affiliation
SECRETARIA DE SALUD
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Each participant will be evaluated a week after the treatment.
Citations:
PubMed Identifier
22892729
Citation
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.
Results Reference
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Incidence of Post-operative Pain After Single-visit Versus Two-visit Treatment
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