- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07290192
This Study Compares Two Different Ways of Cleaning and Shaping Root Canals During Root-canal Treatment: the Step-down Technique and the Step-back Technique. Iu Want to Find Out Which Method Causes Less Pain After the Procedure. Patients Will be Randomly Placed Into One of the Two Groups, Treated Wit
Comparison of Impact of Step Down Verses Step Back Preparation Technique of Root Canals on Post Operative Pain in Patients Having Pulp Necrosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized clinical trial designed to compare the effects of two root canal preparation techniques-step-back and step-down-on postoperative pain in patients diagnosed with pulp necrosis. Participants will be randomly assigned to one of the two groups.
In the step-down group, root canal shaping will begin at the coronal portion and gradually progress toward the apex, while in the step-back group, preparation will start at the apical portion and move backward toward the coronal area. Postoperative pain will be assessed at multiple time points using a standardized pain scale (e.g., Visual Analog Scale).
The aim of the study is to determine which technique causes less pain after treatment, helping clinicians choose the method that improves patient comfort following root canal therapy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kokab Naeem
- Phone Number: 03340053288
- Email: kokabnaeem472@gmail.com
Study Contact Backup
- Name: AFPGMI Rawalpindi
- Phone Number: 05156131187
- Email: admin@afpgmi.edu.pk
Study Locations
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Punjab Province
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Rawalpindi, Punjab Province, Pakistan, 46000
- Armed forces post graduate medical institute Rawalpindi ,Punjab Pakistan 46000
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Contact:
- G1 Training Training
- Phone Number: 05156131187
- Email: admin@afpgmi.edu.pk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients age between 18 to 65 years Healthy patients with ASA classification 1 and 2 Patients of both genders Patients who agreed to attend recall appointments Patients having single rooted tooth with pulp necrosis without pre-existing periapical pathosis and apical periodontitis
Exclusion Criteria:
- Patients with history of chronic pain Previously RCT treated tooth Teeth with apical pathosis ,with irreversible pulpitis Patients having systemic illness Multirooted teeth Patients consumed analgesics between appointments Teeth with calcified canals Cases of root fracture Children Pregnant and lactating mothers Smokers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Step back technique of root canal Vs step down technique of root canal
Arm 1: Step-Down Technique Arm Type: Experimental Arm Title: Step-Down Root Canal Preparation Arm Description: Participants in this arm will receive root canal preparation using the step-down technique, where shaping begins in the coronal portion of the canal and progresses toward the apex. This method is designed to improve irrigation and reduce debris extrusion. --- Arm 2: Step-Back Technique Arm Type: Experimental Arm Title: Step-Back Root Canal Preparation Arm Description: Participants in this arm will receive root canal preparation using the step-back technique, where shaping starts at the apical portion and moves step-by-step backward toward the coronal area using progressively larger files. This conventional method serves as the comparison technique. |
Step-Down Root Canal Preparation Experimental Step-Down Technique Procedure Root canal preparation starts at the coronal portion of the canal and progresses toward the apex using endodontic files of decreasing size. Aims to improve irrigation, reduce debris extrusion, and minimize postoperative pain. Step-Back Root Canal Preparation Active Comparator Step-Back Technique Procedure Root canal preparation starts at the apical portion of the canal and progresses stepwise toward the coronal portion using progressively larger files. Serves as the conventional comparator technique to evaluate postoperative pain |
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Experimental: Arm 1 Arm Type: Experimental Arm Title: Step-Down Preparation Technique Detailed Description: Pa
Participants in arm 1 will receive root canal preparation using the step-down technique, where shaping begins at the coronal portion of the canal and gradually progresses toward the apex. This method is intended to improve irrigation, reduce debris extrusion, and potentially lower postoperative pain. Participants arm 2 will receive root canal preparation using the step-back technique, where shaping starts at the apical portion and moves stepwise toward the coronal area using progressively larger files. This conventional method serves as the comparator to evaluate differences in postoperative pain and treatment outcomes. |
Step-Down Root Canal Preparation Experimental Step-Down Technique Procedure Root canal preparation starts at the coronal portion of the canal and progresses toward the apex using endodontic files of decreasing size. Aims to improve irrigation, reduce debris extrusion, and minimize postoperative pain. Step-Back Root Canal Preparation Active Comparator Step-Back Technique Procedure Root canal preparation starts at the apical portion of the canal and progresses stepwise toward the coronal portion using progressively larger files. Serves as the conventional comparator technique to evaluate postoperative pain |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative pain in patients undergoing root canal treatment using two techniques step back and step down in patients having pulp necrosis
Time Frame: 6 months of duration
|
Patients randomly assigned in two groups Group A patients in which root canal treatment is done using step back technique Group B patients in which root canal treatment is done using step down technique Pain is assessed using visual analog scale ranging from 0(no pain) to 10 worst pain possible.Patients record their pain at 12,24,48 72 hours.Pain diaries will be collected at one week follow up.Data will be used to compare mean VAS between groups to evaluate the efficacy of two techniques.
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6 months of duration
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCT-2025-pain-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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