Pain
Conditions
Keywords
Root canal treatment, pain, endodontic instruments
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.
Detailed description
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.
Interventions
Sponsors
Zahedan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Systematically healthy patients * First or second molars with irreversible pulpitis without periapical pathosis. * Single visit endodontic treatment
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval | 6 hours | 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). |
| 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 | — |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control K-file hand instrumentation
Control: K-file hand instrumentation | 50 |
| Reciproc rotary reciprocating protocol
Reciproc: reciprocating rotary instrument | 50 |
| One Shape one shape continuous rotation protocol
One shape: full rotation protocol | 50 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 5 |
Baseline characteristics
| Characteristic | Reciproc | One Shape | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 33.2 years STANDARD_DEVIATION 13.7 | 30.2 years STANDARD_DEVIATION 10.1 | 31.7 years STANDARD_DEVIATION 13.4 | 31.7 years STANDARD_DEVIATION 12.3 |
| Sex: Female, Male Female | 31 Participants | 34 Participants | 27 Participants | 92 Participants |
| Sex: Female, Male Male | 19 Participants | 16 Participants | 23 Participants | 58 Participants |
| Tooth type Mandibular molars | 39 participants | 30 participants | 25 participants | 94 participants |
| Tooth type Maxillary molars | 11 participants | 20 participants | 25 participants | 56 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval | 0.72 units on a scale | Standard Deviation 0.19 |
| Reciproc | Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval | 0.46 units on a scale | Standard Deviation 0.26 |
| One Shape | Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval | 0.34 units on a scale | Standard Deviation 0.15 |
Primary
Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals | 0.46 units on a scale | Standard Deviation 0.26 |
| Reciproc | Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals | 0.34 units on a scale | Standard Deviation 0.15 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval | 5 units on a scale | Standard Deviation 2.8 |
| Reciproc | Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval | 3.2 units on a scale | Standard Deviation 3.1 |
| One Shape | Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval | 3.5 units on a scale | Standard Deviation 2.9 |