Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive

Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive In Instrumentation Of Necrotic Mandibular Molars: A Randomized Clinical Trial

assess the effect of using reciprocating motion with reciproc files versus adaptive motion using twisted file adaptive on postoperative pain after instrumentation of necrotic mandibular molars.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: Twisted file adaptive; Device: Reciproc

Detailed Description

In root canal treatment of mandibular molar teeth in patients having necrotic pulp with symptomatic or asymptomatic apical periodontitis, Is there difference in postoperative pain after instrumentation between two different kinematics; adaptive motion using Twisted File Adaptive and reciprocation motion using Reciproc

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: abu bakr; Phone Number: +201225877183; Email: ahmed.abubakr@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who are medically free from any systemic disease that may contraindicate our interventions.
2. Patient's age between 18-60 years old.
3. Mandibular molars having necrotic pulps with symptomatic or asymptomatic apical periodontitis because this group of patients may have more postoperative pain than vital teeth22.
4. Positive patient's acceptance for participation in the study.

Exclusion Criteria:

1. Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain after instrumentation.
2. Teeth with vital pulps or Symptomatic irreversible pulpitis.
3. Pregnant patients or lactating because of radiographic hazards and use of analgesics27.
4. Any known sensitivity or adverse reactions to ibuprofen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Twisted file adaptive; Files that are used in root canal preparation in adaptive motion	Device: Twisted file adaptive; Endodontic files that are used in preparation of root canals with adaptive motion
Active Comparator: Reciproc; Reciproc files are used in root canal preparation with reciprocation motion	Device: Reciproc; Endodontic files that are used in root canal preparation with reciprocation motion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post instrumentation pain	post instrumentation pain will be recorded by the patient using numerical rating scale (0-10) will be used to record pain intensity	up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesic intake	number of analgesic intake will be recorded by the patient	up to 7 days
Colony forming units	calculation of colony forming units before and after instrumentation	6 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: postoperative pain; reciproc; twisted file adaptive
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: twisted file adaptive 1987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: participant data will be recorded and shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes