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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06081335

Enrollment

Registered

2023-10-13

Start date

2023-03-15

Completion date

2023-06-05

Last updated

2023-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis, Irreversible Pulpitis, Pain, Postoperative

Keywords

pain, substance P, continuous rotation, reciprocation

Brief summary

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.

Interventions

DEVICEEdgeEndo x7 continuous rotation files

endodontic files operating in continuous rotation

DEVICEEdgeOne Fire reciprocating files

endodontic files operating in reciprocating motion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
difference in substance P levels	pre-operatively and after 5 days at the beginning of the second visit	tested by radioimmunacy (ELISA)
post operative pain levels	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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026