An interventional study of Rotary Crown Down Technique and Manual Step Back Technique in Irreversible Pulpitis, Symptomatic Irreversible Pulpitis and Asymptomatic Irreversible Pulpitis, sponsored by Urooj Fatima. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Urooj Fatima · Not applicable, Interventional, and 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.
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.
316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.
This study's planned enrollment of 70 is close to the median of 64 across 288 interventional studies indexed under Pulpitis.
Browse Pulpitis studies →Urooj Fatima is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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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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patients undergoing root canal treatment with rotary crown down technique
Other: Rotary Crown Down Technique
Patients undergoing root canal treatment with manual step back technique
Other: Manual Step Back Technique
Root canal treatment with rotary instrument is done using crown down approach and post endodontic pain measured after 4,12,24,48 hours.
Root canal treatment with manual instruments using step back technique and post endodontic pain measured at 4,12,24,48 hours .
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
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Oct 2025, 5 months later.
Of 158 non-industry interventional studies with no phase under Pulpitis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's planned 5 months is below that.
Counting every sponsor, half of 158 studies reached it within 16 months; a quarter within 9 and three quarters within 28.
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This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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