Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

NCT ID: NCT05059171

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2021-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

OneSahpe single file

Intervention Type: DEVICE

The rotary motion of OneShape single file

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.

Group Type: ACTIVE_COMPARATOR

WaveOne Gold single file

Intervention Type: DEVICE

reciprocation motions of WaveOne Gold single file

Interventions

OneSahpe single file

The rotary motion of OneShape single file

Intervention Type: DEVICE

WaveOne Gold single file

reciprocation motions of WaveOne Gold single file

Intervention Type: DEVICE

Eligibility Criteria

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.

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• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Elheeny

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ngwa Khattab

Minya, Minya Governorate, Egypt

Countries

Egypt

Other Identifiers

122/2020

Identifier Type: -

Identifier Source: org_study_id