Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Device: OneSahpe single file; Device: WaveOne Gold single file

• Registration Number: NCT05059171
• Lead Sponsor: Minia University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-16
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-09
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-16
• Last Update Submitted: 2021-09-16
• Study First Posted: 2021-09-28
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotary motion using OneShape single file	OneSahpe 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.
Reciprocating motion using WaveOne Gold single file	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	One week	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

Trial Locations

Locations (1)

Ngwa Khattab; 🇪🇬 Minya, Minia, Egypt