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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2023-06-05

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.

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Detailed Description

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Conditions

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Pain, Postoperative Irreversible Pulpitis Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Continuous Rotation group

EdgeEndo x7 continuous rotation files system (Albuquerque, New Mexico, USA)

Group Type ACTIVE_COMPARATOR

EdgeEndo x7 continuous rotation files

Intervention Type DEVICE

endodontic files operating in continuous rotation

Reciprocation group

EdgeOne Fire reciprocating files system (Albuquerque, New Mexico, USA)

Group Type ACTIVE_COMPARATOR

EdgeOne Fire reciprocating files

Intervention Type DEVICE

endodontic files operating in reciprocating motion

Interventions

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EdgeEndo x7 continuous rotation files

endodontic files operating in continuous rotation

Intervention Type DEVICE

EdgeOne Fire reciprocating files

endodontic files operating in reciprocating motion

Intervention Type DEVICE

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

1. The presence of any systemic disease or allergic reactions
2. Pregnant and lactating females
3. Patients on antibiotic or anti-inflammatory medication
4. Use of analgesics a week prior to treatment
5. A radiographically untraceable canal or an excessively curved root
6. The presence of periapical radiolucency or sinus tract.
7. Teeth with open apices
8. Severe periodontal disease (generalized or localized to the tooth in question)
9. Absence of bleeding in the pulp chamber on access cavity preparation
10. Internal or external resorption

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes