Irreversible PulpitisNCT06842251
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
A study testing Rotary Crown Down Technique and Manual Step Back Technique in people with Irreversible Pulpitis and Symptomatic Irreversible Pulpitis, run by Urooj Fatima at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irreversible Pulpitis, Symptomatic Irreversible Pulpitis, Asymptomatic Irreversible Pulpitis
- What is being tested?
- Rotary Crown Down Technique and Manual Step Back Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:1.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
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Exclusion Criteria: 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.
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Trial locations and contacts
1 site in 1 country.
Dr. Lubna Pasha contact
Pakistan1 site
Margalla Institute of Health Sciences
Rawalpindi, Punjab Province
Prof Dr Amjad Mehmood, BDS. FDS RCSEd FDTFEd, 051-5509640, hod_cdm@margalla.edu.pk
About this study
Official title: A COMPARISON of EFFECT of TWO INSTRUMENTATION TECHNIQUES on the INCIDENCE of POST-ENDODONTIC PAIN in PATIENTS UNDERGOING ROOT CANAL TREATMENT
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.
Read the detailed description
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
- Irreversible Pulpitis, Symptomatic Irreversible Pulpitis, Asymptomatic Irreversible Pulpitis
- Being tested
- Rotary Crown Down Technique, Manual Step Back Technique
- Keywords
- Symptomatic Irreversible Pulpitis, Asymptomatic Irreversible Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotary Crown Down TechniqueOther
Root canal treatment with rotary instrument is done using crown down approach and post endodontic pain measured after 4,12,24,48 hours.
Manual Step Back TechniqueOther
Root canal treatment with manual instruments using step back technique and post endodontic pain measured at 4,12,24,48 hours .
| Study group | Role | What they receive |
|---|---|---|
| Group A : Rotary Crown Down Technique | Active comparator | patients undergoing root canal treatment with rotary crown down technique Receives: Other: Rotary Crown Down Technique |
| Group B : Manual Step Back Technique | Active comparator | Patients undergoing root canal treatment with manual step back technique Receives: Other: Manual Step Back Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urooj Fatima
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Urooj Fatima, Margalla Institute of Health Sciences
- Investigators
- Urooj Fatima, Post Graduate Trainee, Principal investigator, Margalla Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842251
- Sponsor's protocol ID
- DU/249/24
- Status last verified
- Sep 2024
- First submitted
- 7 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A COMPARISON of EFFECT of TWO INSTRUMENTATION TECHNIQUES on the INCIDENCE of POST-ENDODONTIC PAIN in PATIENTS UNDERGOING ROOT CANAL TREATMENT
- ClinicalTrials.gov ID
- NCT06842251
- Acronym / sponsor ID
- DU/249/24
- Conditions
- Irreversible Pulpitis, Symptomatic Irreversible Pulpitis, Asymptomatic Irreversible Pulpitis
- Keywords
- Symptomatic Irreversible Pulpitis, Asymptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Urooj FatimaUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 24 Feb 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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : Rotary Crown Down Technique | Active comparator | Other: Rotary Crown Down Techniquepatients undergoing root canal treatment with rotary crown down technique |
| Group B : Manual Step Back Technique | Active comparator | Other: Manual Step Back TechniquePatients undergoing root canal treatment with manual step back technique |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Rotary Crown Down TechniqueRoot canal treatment with rotary instrument is done using crown down approach and post endodontic pain measured after 4,12,24,48 hours. | Other | Group A : Rotary Crown Down Technique |
| Manual Step Back TechniqueRoot canal treatment with manual instruments using step back technique and post endodontic pain measured at 4,12,24,48 hours . | Other | Group B : Manual Step Back Technique |
Primary outcome
Post endodontic pain
Time frame: 6 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dr. Lubna Pasha contact
Urooj Fatima, Post Graduate Trainee principal investigator
Margalla Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotary Crown Down Technique and Manual Step Back Technique in people with Irreversible Pulpitis and Symptomatic Irreversible Pulpitis, run by Urooj Fatima 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?
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: status not confirmed, as of the sponsor's last update on 24 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Urooj Fatima (+923165325070, geturoojfatima@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post endodontic pain (time frame: 6 months). 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 24 Feb 2025.