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Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
OneSahpe single file
WaveOne Gold single file
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Children ages from 4 to 8 years classified as class I or II according to the American Society of Anesthesiologists (ASA).
  2. No previous dental experience.
  3. Non-vital primary molar (necrotic or with chronic apical periodontitis) which confirmed radiographicly with the presence or absence of periapical radiolucency.
  4. Severe tooth mobility.

Exclusion Criteria:

  1. Severe behaviour or emotional disabilities.
  2. Analgesic intake in the preceding 12 hours.
  3. Non-restorable crowns of primary molars.
  4. Radiographic presence of internal root resorption or massive bone destruction.
  5. Root resorption exceeded one-third of the root length.

    -

Sites / Locations

  • Ngwa Khattab

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rotary motion using OneShape single file

Reciprocating motion using WaveOne Gold single file

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2021
Last Updated
September 16, 2021
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT05059171
Brief Title
Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files
Official Title
Postoperative Pain After Pulpectomy of Primary Molars Using With Rotary Versus Reciprocation Motions of Two Single Files: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotary motion using OneShape single file
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Reciprocating motion using WaveOne Gold single file
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
OneSahpe single file
Intervention Description
The rotary motion of OneShape single file
Intervention Type
Device
Intervention Name(s)
WaveOne Gold single file
Intervention Description
reciprocation motions of WaveOne Gold single file
Primary Outcome Measure Information:
Title
Postoperative pain
Description
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
Time Frame
One week

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
children aged from 4 to 8 years
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Facility Information:
Facility Name
Ngwa Khattab
City
Minya
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt

12. IPD Sharing Statement

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Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

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