Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

Minia University

Status: Completed

Conditions: Postoperative Pain

Treatments: Device: WaveOne Gold single file; Device: OneSahpe single file

Study type: Interventional

Funder types: Other

Identifiers

NCT05059171

122/2020

Details and patient eligibility

About

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).

Enrollment: 260 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

Rotary motion using OneShape single file

Active Comparator group

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.

Treatment:

Device: OneSahpe single file

Reciprocating motion using WaveOne Gold single file

Active Comparator group

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.

Treatment:

Device: WaveOne Gold single file