Pulp NecrosisNCT07290192
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
A study testing Step down technique in people with Pulp Necrosis, run by Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulp Necrosis
- What is being tested?
- Step down technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Armed forces post graduate medical institute Rawalpindi ,Punjab Pakistan 46000
Rawalpindi, Punjab Province, 46000
G1 Training Training, 05156131187, admin@afpgmi.edu.pk
About this study
Official title: Comparison of Impact of Step Down Verses Step Back Preparation Technique of Root Canals on Post Operative Pain in Patients Having Pulp Necrosis
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.
Read the 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.
- Conditions
- Pulp Necrosis
- Being tested
- Step down technique
- Keywords
- Post operative pain, Pulp necrosis, Step back technique, Step down technique
- Medical subject headings
- Dental Pulp Necrosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step down techniqueProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Step down technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months of duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kokab Naeem, Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290192
- Sponsor's protocol ID
- RCT-2025-pain-02
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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 .
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Impact of Step Down Verses Step Back Preparation Technique of Root Canals on Post Operative Pain in Patients Having Pulp Necrosis
- ClinicalTrials.gov ID
- NCT07290192
- Acronym / sponsor ID
- RCT-2025-pain-02
- Conditions
- Pulp Necrosis
- Keywords
- Post operative pain, Pulp necrosis, Step back technique, Step down technique
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Armed Forces Post Graduate Medical Institute (AFPGMI), RawalpindiUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step back technique of root canal Vs step down technique of root canal | Experimental | Procedure: Step down techniqueArm 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. |
| Arm 1 Arm Type: Experimental Arm Title: Step-Down Preparation Technique Detailed Description: Pa | Experimental | Procedure: Step down techniqueParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step down techniqueStep-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 | Procedure or surgery | Arm 1 Arm Type: Experimental Arm Title: Step-Down Preparation Technique Detailed Description: Pa, Step back technique of root canal Vs step down technique of root canal |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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 .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step down technique in people with Pulp Necrosis, run by Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kokab Naeem (03340053288, kokabnaeem472@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.