NCT06842251

Brief Summary

The aim of this study is to compare the post endodontic pain in patients presenting with irreversible pulpitis and undergoing root canal treatment with two techniques. One is rotary crown down technique and other is manual step back technique. Patients visiting OPD will be selected after fulfilment of inclusion criteria and randomly divided into two groups. In Group A rotary instrument with Crown Down approach is used and in Group B manual instrumentation with Step Back technique is used. Post endodontic pain will be graded using VAS scale at 4,12,24 and 48 hours.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 7, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

February 24, 2025

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

February 7, 2025

Last Update Submit

February 18, 2025

Conditions

Keywords

Symptomatic Irreversible PulpitisAsymptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

  • Post endodontic pain

    post operative pain measured through visual analogue scale(VAS) from readings no pain 0, mid pain taken as 0-2, moderate as 2-5, severe taken as 5-10

    6 months

Study Arms (2)

Group A : Rotary Crown Down Technique

ACTIVE COMPARATOR

patients undergoing root canal treatment with rotary crown down technique

Other: Rotary Crown Down Technique

Group B : Manual Step Back Technique

ACTIVE COMPARATOR

Patients undergoing root canal treatment with manual step back technique

Other: Manual Step Back Technique

Interventions

Root canal treatment with rotary instrument is done using crown down approach and post endodontic pain measured after 4,12,24,48 hours.

Group A : Rotary Crown Down Technique

Root canal treatment with manual instruments using step back technique and post endodontic pain measured at 4,12,24,48 hours .

Group B : Manual Step Back Technique

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Margalla Institute of Health Sciences

Rawalpindi, Punjab Province, Pakistan

Location

Study Officials

  • Urooj Fatima, Post Graduate Trainee

    Margalla Institute of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Lubna Pasha

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Post Graduate Trainee

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 24, 2025

Study Start

May 1, 2025

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

February 24, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations