Comparison Between Reciproc and Protaper Next

NCT02946099 | Completed

• 1 other identifier: reciproc_protapernext
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Pulp Necrosis

Outcome Measures

Primary Outcomes (2)

• Post operative pain assessed with the Numerical Rating Pain Scale

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

  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

  up to 24 hours following obturation

Secondary Outcomes (1)

• Time required to complete instrumentation

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

Study Arms (2)

Reciproc file

EXPERIMENTAL

Reciproc files in reciprocating motion

Procedure: Reciproc files in reciprocating motion

ProTaper Next file

ACTIVE COMPARATOR

ProTaper Next files in continuous rotary motion

Procedure: ProTaper Next files in continuous rotary motion

Interventions

Reciproc files in reciprocating motion PROCEDURE

An endodontic file that works through a reciprocating motion

Reciproc file

ProTaper Next files in continuous rotary motion PROCEDURE

An endodontic file that works through a continuous rotary motion

ProTaper Next file

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, 52431, Egypt

Location

Related Publications (2)

• 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.

  PMID: 25720984 BACKGROUND

• 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.

  PMID: 22595125 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Endodontic department Faculty of Oral and Dental Medecine, Cairo University

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 26, 2016
• Study Start: November 1, 2016
• Primary Completion: October 14, 2017
• Study Completion: November 1, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)