Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

NCT05059171 | Completed

• 1 other identifier: 122/2020
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Device: OneSahpe single file

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.

Device: WaveOne Gold single file

Interventions

OneSahpe single file DEVICE

The rotary motion of OneShape single file

Rotary motion using OneShape single file

WaveOne Gold single file DEVICE

reciprocation motions of WaveOne Gold single file

Reciprocating motion using WaveOne Gold single file

Eligibility Criteria

• Age: 4 Years - 8 Years
• Gender Eligibility Details: children aged from 4 to 8 years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Ngwa Khattab

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 28, 2021
• Study Start: November 16, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

EG (1)