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
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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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2025-05-01
2025-11-01
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A : Rotary Crown Down Technique
patients undergoing root canal treatment with rotary crown down technique
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.
Group B : Manual Step Back Technique
Patients undergoing root canal treatment with manual step back technique
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 .
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.
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 .
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Urooj Fatima
OTHER
Responsible Party
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Urooj Fatima
Post Graduate Trainee
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
Countries
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Central Contacts
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Dr. Lubna Pasha
Role: CONTACT
Facility Contacts
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Other Identifiers
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DU/249/24
Identifier Type: -
Identifier Source: org_study_id
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