Pain Intensity After Root Canal Instrumentation

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04216940
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

Assess the pain intensity in a two visit treatment of molars with irreversible pulpitis after instrumentation with two rotary systems Mpro and Hyflex files.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Device: mechanical preparation of root canal system	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Assessment of Pain Intensity After Instrumentation by MPRo and Hyflex Rotatry Files in Molars With Irreversible Pulpitis
• Actual Study Start Date: Feb 10, 2019
• Actual Primary Completion Date: Aug 28, 2019
• Actual Study Completion Date: Aug 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: M-pro	Device: mechanical preparation of root canal system; Assess the pain intensity in a two-visit treatment of molars with irreversible pulpitis after instrumentation with two different rotary Nickle Titanium systems
Experimental: Hyflex	Device: mechanical preparation of root canal system; Assess the pain intensity in a two-visit treatment of molars with irreversible pulpitis after instrumentation with two different rotary Nickle Titanium systems

Outcome Measures

Primary Outcome Measures

1. Pain felt after mechanical instrumentation in the first visit [up to 72 hours]

   using Numeric Rating Scale (NRS) the participant will be asked to verbally rate their pain on a scale from 0 to 10, with 0 equal to no pain and 10 equal to worst possible pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• mandibular molars with acute pulpitis

Exclusion Criteria:

• badly decayed non-restorable molars

• medically compromised patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maram Obeid, Ass. Prof., Ain Shams University
• ClinicalTrials.gov Identifier: NCT04216940
• Other Study ID Numbers: pain intensity
• First Posted: Jan 3, 2020
• Last Update Posted: Jan 3, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Pain

Study Results

No Results Posted as of Jan 3, 2020