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Completed

NCT Number: NCT02946099

Comparison Between Reciproc and Protaper Next

Comparing the postoperative pain resulting after mechanical instrumentation using Reciproc reciprocating files versus that resulting after using ProTaper Next rotary files in asymptomatic necrotic molars.

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Key information

Conditions

Dental Pulp Necrosis Dental Pulp Diseases Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

15 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university

Cairo, 52431, Egypt

About this study

Asymptomatic Necrotic molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using Reciproc Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24 and 48 hours post-instrumentation. The tooth is then temporized and after 1 week obturation is then and post obturation pain is assessed using the Numerical Rating scale after 12 and 24 hours following obturation. The time required to complete instrumentation is also measured and compared using the two files.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Mandibular molar teeth with no pain, no response of pulp tissue to pulp testing and teeth with apical periodontitis

Exclusion criteria

  • Patients on medication for chronic pain
  • Patients with pre-operative pain.
  • Patients having significant systemic disorders.
  • Patients with two or more adjacent teeth requiring root canal therapy
  • teeth that have vital pulp tissues, greater than grade I mobility, pocket depth greater than 5 mm, no possible restorability or previous endodontic treatment.

Treatment and study plan

Reciproc files in reciprocating motion

Procedure

An endodontic file that works through a reciprocating motion

ProTaper Next files in continuous rotary motion

Procedure

An endodontic file that works through a continuous rotary motion

Primary outcomes

  1. Post operative pain assessed with the Numerical Rating Pain Scale

    Time frame: Up to 48 hours post-instrumentation

    1 to 10 Numerical Rating Pain Scale up to 48 hours post-instrumentation

  2. Post-obturation pain assessed with the Numerical Rating Pain Scale

    Time frame: up to 24 hours following obturation

    1 to 10 Numerical Rating Pain Scale up to 24 hours following obturation

Secondary outcomes

  1. Time required to complete instrumentation

    Time frame: From the completion of the access cavity preparation till the end of cleaning and shaping procedure up to 2 hours

    time required to complete instrumentation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison of Postoperative Pain After Root Canal Instrumentation Using Reciproc and ProTaper Next in Asymptomatic Necrotic Molars: A Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 26, 2016
Registry last updated
Nov 7, 2017

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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