Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial

Study Overview
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Brief Summary
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The aim of this study was to evaluate the effect of continuous rotation and reciprocation kinematics on post operative pain and difference in substance P levels in patients with irreversible pulpitis with symptomatic apical periodontitis. Twenty patients were randomly distributed into two groups; Continuous Rotation group(n=10): received mechanical preparation using EdgeEndo x7 rotary system (Albuquerque, New Mexico, USA), while Reciprocation group(n=10): received mechanical preparation using EdgeOne Fire reciprocating system (Albuquerque, New Mexico, USA). Apical fluid(AF) samples were collected, and substance P (SP) levels were measured using radioimmunoassay and postoperative pain was measured using Numerical Rating Scale (NRS) preoperatively, at 6h, 12h, 24h, 48h and 72h.

Official Title
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Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial

Conditions
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Pain, Postoperative, Irreversible Pulpitis, Apical Periodontitis

Intervention / Treatment
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* Device: EdgeEndo x7 continuous rotation files
* Device: EdgeOne Fire reciprocating files


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single rooted mandibular second premolar teeth with complete root formation Pulpal diagnosis: Symptomatic irreversible pulpitis Periapical diagnosis: symptomatic apical periodontitis with no visible periapical radiolucent area Patients with pre-operative pain records above 4 on Numerical Rating Scale (NRS) to ensure standardization Exclusion Criteria: The presence of any systemic disease or allergic reactions Pregnant and lactating females Patients on antibiotic or anti-inflammatory medication Use of analgesics a week prior to treatment A radiographically untraceable canal or an excessively curved root The presence of periapical radiolucency or sinus tract. Teeth with open apices Severe periodontal disease (generalized or localized to the tooth in question) Absence of bleeding in the pulp chamber on access cavity preparation Internal or external resorption

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Rotation group<br>EdgeEndo x7 continuous rotation files system (Albuquerque, New Mexico, USA) | Device: EdgeEndo x7 continuous rotation files<br>* endodontic files operating in continuous rotation<br>|
| Active Comparator: Reciprocation group<br>EdgeOne Fire reciprocating files system (Albuquerque, New Mexico, USA) | Device: EdgeOne Fire reciprocating files<br>* endodontic files operating in reciprocating motion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in substance P levels | tested by radioimmunacy (ELISA) | pre-operatively and after 5 days at the beginning of the second visit | 
| post operative pain levels | Numerical Rating Scale was used to assess pain where 0 is no pain and 10 is the worst possible pain | pre-operative, after 6 hours, 12 hours , 24 hours, 48 hours, 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, substance P, continuous rotation, reciprocation