Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

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

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: OneSahpe single file; Device: WaveOne Gold single file

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minia
    • Minya, Minia, Egypt, 61111
      • Ngwa Khattab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

   -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rotary motion using OneShape single file; 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; The rotary motion of OneShape single file
Active Comparator: Reciprocating motion using WaveOne Gold single file; 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; reciprocation motions of WaveOne Gold single file

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 122/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No