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Completed

NCT Number: NCT05059171

Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

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).

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Key information

Conditions

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

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ngwa Khattab

Minya, Minya Governorate, 61111, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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Treatment and study plan

OneSahpe single file

Device

The rotary motion of OneShape single file

WaveOne Gold single file

Device

reciprocation motions of WaveOne Gold single file

Primary outcomes

  1. Postoperative pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2021
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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