Postoperative Pain Assessment After Using Different Kinematics

Postoperative Pain Assessment After Using Different Kinematics During Endodontic Instrumentation (Randomized Clinical Trial)

The aim of this study is to evaluate postoperative pain after endodontic instrumentation using rotation, reciprocation and adaptive motion.

Study Overview

• Status: Completed
• Conditions: Root Canal Therapy
• Intervention / Treatment: Procedure: Root canal therapy

Detailed Description

Post operative pain assessment is done at the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, with 0 representing no pain and 10 representing the most severe pain imaginable.These scores were marked in intervals of 6, 12, 24, 48 and 72 h following endodontic treatment.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry, Ainshams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Medically free patients with good health.
2. Patient's age between 18_50
3. Mandibular first molars teeth diagnosed clinically and radiographically as acute irreversible pulpitis with no evidence of apical pathosis
4. Positive patient's acceptance for participation in the study

Exclusion Criteria:

• Root resorption
• Non restorable teeth.
• Pregnancy.
• Systematic disease as hypertension ,diabetes .
• Psychologically disturbance.
• Need for prophylactic antibiotics

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continous rotation; instrumentation was done in continuous rotation motion	Procedure: Root canal therapy; Different types of instrumentation motions during root canal therapy
Active Comparator: Reciprocation; instrumentation was done in reciprocation motion	Procedure: Root canal therapy; Different types of instrumentation motions during root canal therapy
Active Comparator: Adaptive motion; instrumentation was done in adaptive motion	Procedure: Root canal therapy; Different types of instrumentation motions during root canal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monitoring the change in postoperative pain following root canal treatment	At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-hour post operative pain assessment	At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 6 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain	6 hours
12-hour post operative pain assessment	At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 12 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain	12 hours
24-hour post operative pain assessment	At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 24 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Ahmed Hashem, PhD, Faculty of Dentistry, Ain Shams University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 24, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ASFD-ENDO-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No