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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06081335
• Other study ID #: 945
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: June 5, 2023

Study information

• Verified date: November 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 5, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Apical Periodontitis
• Irreversible Pulpitis
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis
• Pulpitis

Intervention

Device:
• EdgeEndo x7 continuous rotation files
endodontic files operating in continuous rotation
• EdgeOne Fire reciprocating files
endodontic files operating in reciprocating motion

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Select A State Or Province
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

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