Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment

Acute Pulpitis Clinical Trial

Official title:

Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment: A Blinded Randomized Clinical Trial Therapeutic Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412318
• Other study ID #: TF vs Mpro
• Status: Completed
• Phase: N/A
• Start date: October 6, 2018
• Est. completion date: January 22, 2020

Study information

• Verified date: February 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to comparatively evaluate the post operative pain between root canal preparation by reciprocating file (TF) and full rotation file (M-Pro) in patients with single rooted teeth with acute irreversible pulpits.

Description:

Teeth with symptomatic irreversible pulpitis are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment after using Twisted files or M-pro files. The treatment is done in single visit. The postoperative pain is then assessed using the Numerical Rating Scale 6,12, 24 and 48 hours post-instrumentation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 22, 2020
• Est. primary completion date: September 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients in good health (American Society of Anesthesiologists Class II or higher).

• Patients having symptomatic irreversible pulpitis in their single rooted teeth.

• Age range is between 20 and 60 years.

• Patients who can understand numerical rating scale (NRS).

• Patients able to sign informed consent.

Exclusion Criteria:

• Patients with positive percussion test.

• Patients having history of necrosis with or without apical pathosis.

• Patients have sinus tract or fistula extra oral or intraoral.

• Pregnant or mentally retarded patients.

• Teeth with grade 2 or 3 mobility.

Related Conditions & MeSH terms

• Acute Pulpitis
• Pain, Postoperative
• Pulpitis

Intervention

Device:
• Twisted file
Use of twisted file during cleaning and shaping of root canals
• Mpro
Use of Mpro during cleaning and shaping of root canals

Locations

Country	Name	City	State
Egypt	Ahmad Almorad	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Gambarini G, Testarelli L, De Luca M, Milana V, Plotino G, Grande NM, Rubini AG, Al Sudani D, Sannino G. The influence of three different instrumentation techniques on the incidence of postoperative pain after endodontic treatment. Ann Stomatol (Roma). 2013 Mar 20;4(1):152-5. doi: 10.11138/ads.0152. Print 2013 Jan. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Post-operative pain assessed after treatment using the NRS pain scale	2 days