Comparison Between Reciproc and Protaper Next

Dental Pulp Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946099
• Other study ID #: reciproc_protapernext
• Status: Completed
• Phase: N/A
• First received: October 24, 2016
• Last updated: November 4, 2017
• Start date: November 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2017
• Est. primary completion date: October 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis

Intervention

Procedure:
• Reciproc files in reciprocating motion
An endodontic file that works through a reciprocating motion
• ProTaper Next files in continuous rotary motion
An endodontic file that works through a continuous rotary motion

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Bürklein S, Schäfer 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time required to complete instrumentation	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