To COMPARE the EFFECT of TWO INSTRUMENTATION TECHNIQUES on the INCIDENCE of POST-ENDODONTIC PAIN in PATIENTS UNDERGOING ROOT CANAL TREATMENT in TEETH with IRREVERSIBLE PULPITIS

NCT ID: NCT06842251

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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The main objective of this study was to compare the effect of step back manual and crown down rotary techniques on post endodontic pain in teeth with irreversible pulpitis after root canal treatment .Crown Down technique involves the preparation of the coronal portion of the root canal, followed by the middle and apical third of the root canal .Step Back technique involves initial apical preparation followed by step-wise coronal preparation to create tapers .By using WHO sample size calculator, sample size is 70 having 35 in each group.

Inclusion criteria include patients of both genders having age 18-70 years, no history of analgesics within the past 1 week, subjects with no periapical radiolucency, teeth having completely formed tooth apex, permanent posterior teeth with symptomatic/asymptomatic irreversible pulpitis, subjects who provided the consent for study participation. Exclusion criteria include subjects with a history of trauma, previous root canal treatment, associated systemic diseases, pregnant females ,subjects on analgesics or antibiotics ,complaints of tenderness and pain within the past 5 days, extreme root curvature, calcified canals, external or internal resorption. The study will be conducted after permission from institutional ethics review committee. Patients presenting in Operative outpatient department at Margalla Dental Hospital, Rawalpindi, and fulfilling inclusion criteria will be included in this study.

After ensuring the general health of patients by taking a medical history, the pulp and periapical status of the teeth will be assessed by thermal and electric tests, percussion, palpation, and radiography. The patients will then be briefed about the study, and written informed consent will be obtained from them. Local anesthesia will be administered by an inferior alveolar nerve block with the injection of 1.8 mL lidocaine plus 1:80,000 epinephrine. Optimal depth of anesthesia will be ensured by electric and thermal tests. After ensuring optimal depth of anesthesia, the access cavity will be prepared, and the orifices will be negotiated and canals will be instrumented by the crown down rotary or step down manual technique based on the group allocation of the teeth. The patients will not be aware of the technique used for their endodontic treatment. VAS scale will be used to grade the post endodontic pain at different time intervals after procedure at 4,12,24 and 48 hours. All data will be recorded in a specially designed Performa. Data will be entered in SPSS version 24. The data will be expressed in the means and standard deviations. Chi square will be applied and Independent sample t test will be used to evaluate difference in the mean age of the two groups. P \< 0.05 will be considered statistically significant.

Local anesthesia will be administered by an inferior alveolar nerve block with the injection of 1.8 mL lidocaine plus 1:80,000 epinephrine. Optimal depth of anesthesia will be ensured by electric and thermal tests. After ensuring optimal depth of anesthesia, the access cavity will be prepared, and the orifices will be negotiated and canals will be instrumented by the crown down rotary or step down manual technique based on the group allocation of the teeth. The patients will not be aware of the technique used for their endodontic treatment. VAS scale will be used to grade the post endodontic pain at different time intervals after procedure at 4,12,24 and 48+ hours. All data will be recorded in a specially designed performa.Data will be entered in SPSS version 24. The data will be expressed in the means and standard deviations.Independent sample t test will be used to evaluate difference in the mean age of the two groups. P \< 0.05 will be considered statistically significant.

Exclusion criteria include subjects with a history of trauma, previous root canal treatment ,associated systemic diseases ,pregnant females ,subjects on analgesics or antibiotics ,complaints of tenderness and pain within the past 5 days ,extreme root curvature, calcified canals ,external or internal resorption.

Conditions

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Irreversible Pulpitis Symptomatic Irreversible Pulpitis Asymptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group A : Rotary Crown Down Technique

patients undergoing root canal treatment with rotary crown down technique

Group Type ACTIVE_COMPARATOR

Rotary Crown Down Technique

Intervention Type OTHER

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

Group B : Manual Step Back Technique

Patients undergoing root canal treatment with manual step back technique

Group Type ACTIVE_COMPARATOR

Manual Step Back Technique

Intervention Type OTHER

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

Interventions

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Rotary Crown Down Technique

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

Intervention Type OTHER

Manual Step Back Technique

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Urooj Fatima

OTHER

Sponsor Role lead

Responsible Party

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Urooj Fatima

Post Graduate Trainee

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Urooj Fatima, Post Graduate Trainee

Role: PRINCIPAL_INVESTIGATOR

Margalla Institute of Health Sciences

Locations

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Margalla Institute of Health Sciences

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Urooj Fatima

Role: CONTACT

+923165325070

Dr. Lubna Pasha

Role: CONTACT

+923339499959

Facility Contacts

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Prof Dr Amjad Mehmood, BDS. FDS RCSEd FDTFEd

Role: primary

051-5509640

Other Identifiers

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DU/249/24

Identifier Type: -

Identifier Source: org_study_id

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