Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

Study Overview
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Brief Summary
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An equivalent parallel randomized clinical trial was approved by the local University Committee of Ethics. 260 children with necrotic primary molars were allocated into 2 equal groups (82 children per group). The participants were allocated into two groups; group 1 teeth were instrumented with OneShape rotary system (Micro Mega, Besancon, France), and group 2 teeth were instrumented with WaveOne Gold reciprocating system (Dentsply Maillefer, Ballaigues, Switzerland). Postoperative pain was assessed using a four-point pain intensity rating scale adopted from Wong-Baker FACES (WBF) pain scale . The face scale consists of four faces with a brief title describing each face representing a scale from the first face (score 1), second face (score 2), third face (score 3), and forth face (score 4) 3. Postoperative pain was assessed at 6 six time intervals (at 6, 12, 24, 48, 72 hours and one-week).

Official Title
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Postoperative Pain After Pulpectomy of Primary Molars Using With Rotary Versus Reciprocation Motions of Two Single Files: A Randomized Clinical Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Device: OneSahpe single file
* Device: WaveOne Gold single file


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ages from 4 to 8 years classified as class I or II according to the American Society of Anesthesiologists (ASA). No previous dental experience. Non-vital primary molar (necrotic or with chronic apical periodontitis) which confirmed radiographicly with the presence or absence of periapical radiolucency. Severe tooth mobility. Exclusion Criteria: Severe behaviour or emotional disabilities. Analgesic intake in the preceding 12 hours. Non-restorable crowns of primary molars. Radiographic presence of internal root resorption or massive bone destruction. Root resorption exceeded one-third of the root length. -

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rotary motion using OneShape single file<br>File size 25 with a taper of 0.06 was mounted to a 6:1 speed-reduction headpiece powered by X Smart Plus endomotor (Dentsply Maillefer, Ballaigues, Switzerland). The speed and torque were set to 400 rpm and 1 N.cm torque, respectively. In a picking motion without pressure, mechanical preparation began with the first RC two-thirds followed by the next 3 mm followed by the full WL. | Device: OneSahpe single file<br>* The rotary motion of OneShape single file<br>|
| Active Comparator: Reciprocating motion using WaveOne Gold single file<br>A Primary file size 25 a taper of 0.07 was installed to pre-programmed reciprocation angles and speed for the WaveOne system handpiece of an endomotor (X Smart Plus endomotor (Dentsply Maillefer, Ballaigues, Switzerland). After ensuring a passive fit of the hand file along the predetermined WL, the RC coronal two-thirds was initially instrumented then followed by the full WL. | Device: WaveOne Gold single file<br>* reciprocation motions of WaveOne Gold single file<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain was assessed using a four-point pain intensity rating scale adopted from Wong-Baker FACES (WBF) pain scale . The face scale consists of four faces with a brief title describing each face representing a scale from the first face (score 1), second face (score 2), third face (score 3), and fourth face (score 4) 17. Postoperative pain was assessed at 6 six time intervals | One week |