NCT07290192

Brief Summary

This randomized clinical trial aims to compare the step-back and step-down root canal preparation techniques in patients with pulp necrosis. The study will evaluate which technique results in less postoperative pain. Participants will be randomly assigned to one of the two groups. Pain intensity will be recorded at specific time points after the procedure using a standardized pain scale. The goal is to identify the technique that provides better patient comfort after root canal treatment.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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

December 6, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 6, 2025

Last Update Submit

December 6, 2025

Conditions

Keywords

Post operative painPulp necrosisStep back techniqueStep down technique

Outcome Measures

Primary Outcomes (1)

  • Post operative pain in patients undergoing root canal treatment using two techniques step back and step down in patients having pulp necrosis

    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.

    6 months of duration

Study Arms (2)

Step back technique of root canal Vs step down technique of root canal

EXPERIMENTAL

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.

Procedure: Step down technique

Arm 1 Arm Type: Experimental Arm Title: Step-Down Preparation Technique Detailed Description: Pa

EXPERIMENTAL

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.

Procedure: Step down technique

Interventions

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

Arm 1 Arm Type: Experimental Arm Title: Step-Down Preparation Technique Detailed Description: PaStep back technique of root canal Vs step down technique of root canal

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed forces post graduate medical institute Rawalpindi ,Punjab Pakistan 46000

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Links

MeSH Terms

Conditions

Dental Pulp NecrosisPain, Postoperative

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

December 6, 2025

First Posted

December 18, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participation data will not be shared because the study doesn't include plans or infrastructure for long term data storage de- identification and controlled access is needed to protect the participants privacy.Additionally the data set is small and disclosure may increase the risk of reidentification.Summary results will be made available as required .

Locations