The Effect of Different Instrumentation Kinematics on Patients With Symptomatic Apical Periodontitis on the Level of Post Operative Pain and the Amount of Inflammatory Mediators Change

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06081335

Collaborator

(none)

Enrollment

Locations

Arms

8.6

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Irreversible Pulpitis Apical Periodontitis	Device: EdgeEndo x7 continuous rotation files Device: EdgeOne Fire reciprocating files	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

The Effect of Different Instrumentation Kinematics on Post Operative Pain and the Level of Inflammatory Mediators in Patients With Symptomatic Apical Periodontitis

Actual Study Start Date :

Mar 15, 2023

Actual Primary Completion Date :

Oct 5, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Continuous Rotation group

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

Device: EdgeEndo x7 continuous rotation files

endodontic files operating in continuous rotation

Active Comparator: Reciprocation group

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

Device: EdgeOne Fire reciprocating files

endodontic files operating in reciprocating motion

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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