Comparative Evaluation of Post-endodontic Pain Using Two Rotary Instrumentation Systems
Comparison of Post-endodontic Pain Using Reciproc and Oneshape Rotary Instrumentation Systems: A Randomized Clinical Trial
1 other identifier
interventional
150
1 country
1
Brief Summary
In this study the investigators aim to compare the post-operative pain using two single-file endodontic rotary systems : Reciproc and One shape.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Dec 2015
Shorter than P25 for not_applicable pain
1 active site
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
First Submitted
Initial submission to the registry
November 29, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
June 6, 2016
CompletedJune 6, 2016
March 1, 2016
2 months
November 29, 2015
March 18, 2016
April 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval
The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
6 hours
Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals
72 hours
Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval
72 hours
Study Arms (3)
Control
EXPERIMENTALK-file hand instrumentation
Reciproc
EXPERIMENTALrotary reciprocating protocol
One shape
EXPERIMENTALone shape continuous rotation protocol
Interventions
Eligibility Criteria
You may qualify if:
- Systematically healthy patients
- First or second molars with irreversible pulpitis without periapical pathosis.
- Single visit endodontic treatment
You may not qualify if:
- Root canal retreatment
- Pregnancy
- The presence of a difficult root canal anatomy
- Internal or external resorption
- Teeth with open apices
- Any accident of complication occurred during treatment
- Presence of periapical lesion, abscess or sinus tract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zahedan Dental School
Zahedan, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Seyed Roholla Havaei
- Organization
- Zahedan university of medical sciences
Study Officials
- STUDY DIRECTOR
Eshagh Ali Saberi, DDS,MS
Head of the department of Endodontics, Zahedan university of medical sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2015
First Posted
December 3, 2015
Study Start
December 1, 2015
Primary Completion
February 1, 2016
Study Completion
March 1, 2016
Last Updated
June 6, 2016
Results First Posted
June 6, 2016
Record last verified: 2016-03