Back to resultsPostoperative Pain Assessment After Using Different Kinematics
Primary Purpose
Root Canal Therapy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Root canal therapy
Sponsored by
About this trial
This is an interventional treatment trial for Root Canal Therapy
Eligibility Criteria
Inclusion Criteria:
- Medically free patients with good health.
- Patient's age between 18_50
- Mandibular first molars teeth diagnosed clinically and radiographically as acute irreversible pulpitis with no evidence of apical pathosis
- Positive patient's acceptance for participation in the study
Exclusion Criteria:
- Root resorption
- Non restorable teeth.
- Pregnancy.
- Systematic disease as hypertension ,diabetes .
- Psychologically disturbance.
- Need for prophylactic antibiotics
Sites / Locations
- Faculty of Dentistry, Ainshams University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Continous rotation
Reciprocation
Adaptive motion
Arm Description
instrumentation was done in continuous rotation motion
instrumentation was done in reciprocation motion
instrumentation was done in adaptive motion
Outcomes
Primary Outcome Measures
monitoring the change in postoperative pain following root canal treatment
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
Secondary Outcome Measures
6-hour post operative pain assessment
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 6 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
12-hour post operative pain assessment
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 12 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
24-hour post operative pain assessment
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 24 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04277520
Brief Title
Postoperative Pain Assessment After Using Different Kinematics
Official Title
Postoperative Pain Assessment After Using Different Kinematics During Endodontic Instrumentation (Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate postoperative pain after endodontic instrumentation using rotation, reciprocation and adaptive motion.
Detailed Description
Post operative pain assessment is done at the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, with 0 representing no pain and 10 representing the most severe pain imaginable.These scores were marked in intervals of 6, 12, 24, 48 and 72 h following endodontic treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continous rotation
Arm Type
Active Comparator
Arm Description
instrumentation was done in continuous rotation motion
Arm Title
Reciprocation
Arm Type
Active Comparator
Arm Description
instrumentation was done in reciprocation motion
Arm Title
Adaptive motion
Arm Type
Active Comparator
Arm Description
instrumentation was done in adaptive motion
Intervention Type
Procedure
Intervention Name(s)
Root canal therapy
Intervention Description
Different types of instrumentation motions during root canal therapy
Primary Outcome Measure Information:
Title
monitoring the change in postoperative pain following root canal treatment
Description
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
6-hour post operative pain assessment
Description
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 6 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
Time Frame
6 hours
Title
12-hour post operative pain assessment
Description
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 12 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
Time Frame
12 hours
Title
24-hour post operative pain assessment
Description
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 24 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Medically free patients with good health.
Patient's age between 18_50
Mandibular first molars teeth diagnosed clinically and radiographically as acute irreversible pulpitis with no evidence of apical pathosis
Positive patient's acceptance for participation in the study
Exclusion Criteria:
Root resorption
Non restorable teeth.
Pregnancy.
Systematic disease as hypertension ,diabetes .
Psychologically disturbance.
Need for prophylactic antibiotics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Hashem, PhD
Organizational Affiliation
Faculty of Dentistry, Ain Shams university
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Ainshams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23741536
Citation
Gambarini G, Testarelli L, De Luca M, Milana V, Plotino G, Grande NM, Rubini AG, Al Sudani D, Sannino G. The influence of three different instrumentation techniques on the incidence of postoperative pain after endodontic treatment. Ann Stomatol (Roma). 2013 Mar 20;4(1):152-5. doi: 10.11138/ads.0152. Print 2013 Jan.
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Postoperative Pain Assessment After Using Different Kinematics
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