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Comparison Between Reciproc and Protaper Next

Primary Purpose

Dental Pulp Necrosis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Reciproc files in reciprocating motion

ProTaper Next files in continuous rotary motion

About this trial

This is an interventional treatment trial for Dental Pulp Necrosis

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reciproc file

ProTaper Next file

Arm Description

Reciproc files in reciprocating motion

ProTaper Next files in continuous rotary motion

Outcomes

Primary Outcome Measures

Post operative pain assessed with the Numerical Rating Pain Scale

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

Post-obturation pain assessed with the Numerical Rating Pain Scale

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

Secondary Outcome Measures

Time required to complete instrumentation

time required to complete instrumentation

Full Information

NCT ID

NCT02946099

First Posted

October 24, 2016

Last Updated

November 4, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02946099

Brief Title

Comparison Between Reciproc and Protaper Next

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

October 14, 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Pulp Necrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reciproc file

Arm Type

Experimental

Arm Description

Reciproc files in reciprocating motion

Arm Title

ProTaper Next file

Arm Type

Active Comparator

Arm Description

ProTaper Next files in continuous rotary motion

Intervention Type

Procedure

Intervention Name(s)

Reciproc files in reciprocating motion

Intervention Description

An endodontic file that works through a reciprocating motion

Intervention Type

Procedure

Intervention Name(s)

ProTaper Next files in continuous rotary motion

Intervention Description

An endodontic file that works through a continuous rotary motion

Primary Outcome Measure Information:

Title

Post operative pain assessed with the Numerical Rating Pain Scale

Description

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

Time Frame

Up to 48 hours post-instrumentation

Title

Post-obturation pain assessed with the Numerical Rating Pain Scale

Description

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

Time Frame

up to 24 hours following obturation

Secondary Outcome Measure Information:

Title

Time required to complete instrumentation

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Cairo university

City

Cairo

ZIP/Postal Code

52431

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25720984

Citation

Nekoofar MH, Sheykhrezae MS, Meraji N, Jamee A, Shirvani A, Jamee J, Dummer PM. Comparison of the effect of root canal preparation by using WaveOne and ProTaper on postoperative pain: a randomized clinical trial. J Endod. 2015 May;41(5):575-8. doi: 10.1016/j.joen.2014.12.026. Epub 2015 Feb 24.

Results Reference

background

PubMed Identifier

22595125

Citation

Burklein S, Schafer E. Apically extruded debris with reciprocating single-file and full-sequence rotary instrumentation systems. J Endod. 2012 Jun;38(6):850-2. doi: 10.1016/j.joen.2012.02.017. Epub 2012 Apr 6.

Results Reference

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Comparison Between Reciproc and Protaper Next

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