Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05059171
• Other study ID #: 122/2020
• Status: Completed
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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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Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• OneSahpe single file
The rotary motion of OneShape single file
• WaveOne Gold single file
reciprocation motions of WaveOne Gold single file

Locations

Country	Name	City	State
Egypt	Ngwa Khattab	Minya	Minia

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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