An interventional study of Control and Reciproc in Pain, sponsored by Zahedan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-06.
Sponsored by Zahedan University of Medical Sciences · Not applicable, Interventional, and Treatment
In this study the investigators aim to compare the post-operative pain using two single-file endodontic rotary systems : Reciproc and One shape.
Comparison of the post operative pain with two rotary systems including Reciproc and One shape.
Confounding factors were neutralized and the rotary systems were compared.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 150 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Zahedan University of Medical Sciences is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
K-file hand instrumentation
Procedure: Control
rotary reciprocating protocol
Procedure: Reciproc
one shape continuous rotation protocol
Procedure: One shape
K-file hand instrumentation
reciprocating rotary instrument
full rotation protocol
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).
Time frame: 6 hours
Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals
Time frame: 72 hours
Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval
Time frame: 72 hours
| Milestone | k File | Reciproc | One Shape |
|---|---|---|---|
| Started | 53 | 52 | 55 |
| Completed | 50 | 50 | 50 |
| Not completed | 3 | 2 | 5 |
| Withdrew: Lost to follow-up | 3 | 2 | 5 |
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).
| units on a scale | Control | Reciproc | One Shape |
|---|---|---|---|
| Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval | 5 ± 2.8 | 3.2 ± 3.1 | 3.5 ± 2.9 |
| units on a scale | Reciproc | One Shape |
|---|---|---|
| Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals | 0.46 ± 0.26 | 0.34 ± 0.15 |
| units on a scale | Control | Reciproc | One Shape |
|---|---|---|---|
| Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval | 0.72 ± 0.19 | 0.46 ± 0.26 | 0.34 ± 0.15 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | — | — |
| Reciproc | — | — | — |
| One Shape | — | — | — |
| Age, Continuous(years) | Control | Reciproc | One Shape | Total |
|---|---|---|---|---|
| Mean | 31.7 ± 13.4 | 33.2 ± 13.7 | 30.2 ± 10.1 | 31.7 ± 12.3 |
| Sex: Female, Male(Participants) | Control | Reciproc | One Shape | Total |
|---|---|---|---|---|
| Female | 27 | 31 | 34 | 92 |
| Male | 23 | 19 | 16 | 58 |
| Tooth type(participants) | Control | Reciproc | One Shape | Total |
|---|---|---|---|---|
| Maxillary molars | 25 | 11 | 20 | 56 |
| Mandibular molars | 25 | 39 | 30 | 94 |
The record gives a start of Dec 2015, a primary completion of Feb 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2016, 4 months after primary completion.
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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Zahedan University of Medical Sciences