Influence of Maintaining Apical Patency on Post-Endodontic Pain in Molars
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCollege of Physicians and Surgeons Pakistan
About this trial
This randomized controlled trial will investigate if maintaining apical patency-a technique where a small file is gently moved past the root's end during cleaning-affects pain after a root canal. The study will include 48 adult patients needing root canal treatment on a back molar tooth with a dead nerve and infection at the root tip. Participants will be randomly assigned to one of two groups: one where the apical patency technique is used, and one where it is not. All other treatment steps will be identical. Patients will record their pain levels on a standard scale (0-100 mm Visual Analog Scale) at 6, 12, 24, 48, and 72 hours after the procedure. The goal is to determine if this specific technique influences the intensity and duration of post-treatment pain
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Patency Group
Procedure/SurgeryThe procedural technique of passively advancing a small endodontic file (size #10 K-file) 1 mm beyond the apical foramen before and after each larger instrument during root canal cleaning and shaping. This is done to prevent blockage of the apical portion of the canal.
Standard Root Canal Instrumentation
Procedure/SurgeryRoot canal instrumentation that is strictly confined to the canal space, terminating at the apical constriction (working length) and avoiding any instrumentation beyond the apical foramen.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Patency GroupExperimental treatment 2 interventions
Group B: Non-Patency GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Post-operative Pain Intensity
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Time frame
6 hours after the completion of the root canal procedure2
Post-operative Pain Intensity at 6 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Time frame
6 hours after the completion of the root canal procedure.3
Post-operative Pain Intensity at 12 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Time frame
12 hours4
Post-operative Pain Intensity at 48 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Time frame
48 hoursSecondary outcomes
1
ncidence of Post-operative Pain Severity
The proportion of participants in each group reporting different levels of pain severity, categorized based on their VAS scores. The categories are: No Pain (VAS = 0 mm), Moderate Pain (VAS = 1-54 mm), and Severe Pain (VAS = 55-100 mm).
Time frame
Assessed at 6, 12, 24, 48, and 72 hours after the procedure2
ncidence of Post-operative Pain Severity
The proportion of participants in each group reporting different levels of pain severity, categorized based on their VAS scores. The categories are: No Pain (VAS = 0 mm), Moderate Pain (VAS = 1-54 mm), and Severe Pain (VAS = 55-100 mm).
Time frame
Assessed at 6, 12, 24, 48, and 72 hours after the procedure. The data from all time points will be aggregated to compare the overall distribution of pain severity between groups.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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