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

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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Key information

Conditions

Pain, Postoperative Apical Periodontitis Irreversible Pulpitis Jaw Diseases Mouth Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Postoperative Complications Signs and Symptoms Stomatognathic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University, Cairo, Select A State Or Province, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EdgeEndo x7 continuous rotation files

Device

endodontic files operating in continuous rotation

EdgeOne Fire reciprocating files

Device

endodontic files operating in reciprocating motion

Primary outcomes

difference in substance P levels

Time frame: pre-operatively and after 5 days at the beginning of the second visit

tested by radioimmunacy (ELISA)
post operative pain levels

Time frame: pre-operative, after 6 hours, 12 hours , 24 hours, 48 hours, 72 hours

Numerical Rating Scale was used to assess pain where 0 is no pain and 10 is the worst possible pain

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Oct 13, 2023
Registry last updated: Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed