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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotary motion using OneShape single file | Active Comparator | 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. |
|
| Reciprocating motion using WaveOne Gold single file | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OneSahpe single file | Device | The rotary motion of OneShape single file |
|
| 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 |
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Inclusion Criteria:
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.
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children aged from 4 to 8 years
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ngwa Khattab | Minya | Minya Governorate | 61111 | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| WaveOne Gold single file | Device | reciprocation motions of WaveOne Gold single file |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |