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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

Primary Purpose

Pain, Postoperative, Irreversible Pulpitis, Apical Periodontitis

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

EdgeEndo x7 continuous rotation files

EdgeOne Fire reciprocating files

About this trial

This is an interventional diagnostic trial for Pain, Postoperative focused on measuring pain, substance P, continuous rotation, reciprocation

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ain Shams UniversityRecruiting
Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Continuous Rotation group

Reciprocation group

Arm Description

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

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

Outcomes

Primary Outcome Measures

difference in substance P levels

tested by radioimmunacy (ELISA)

post operative pain levels

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

Secondary Outcome Measures

Full Information

NCT ID

NCT06081335

First Posted

September 25, 2023

Last Updated

October 11, 2023

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT06081335

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2023 (Actual)

Primary Completion Date

October 5, 2023 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Irreversible Pulpitis, Apical Periodontitis

Keywords

pain, substance P, continuous rotation, reciprocation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Continuous Rotation group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Reciprocation group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

EdgeEndo x7 continuous rotation files

Intervention Description

endodontic files operating in continuous rotation

Intervention Type

Device

Intervention Name(s)

EdgeOne Fire reciprocating files

Intervention Description

endodontic files operating in reciprocating motion

Primary Outcome Measure Information:

Title

difference in substance P levels

Description

tested by radioimmunacy (ELISA)

Time Frame

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

Title

post operative pain levels

Description

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

Time Frame

pre-operative, after 6 hours, 12 hours , 24 hours, 48 hours, 72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

salma osamaa abdelbaset, masters

Phone

+201062168832

salma.talaat117@gmail.com

Facility Information:

Facility Name

Ain Shams University

City

Cairo

State/Province

Select A State Or Province

ZIP/Postal Code

11765

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Salma Talaat, masters

Phone

01062168832

salma.talaat117@gmail.com

Facility Name

Ain Shams University

City

Cairo

ZIP/Postal Code

11765

Country

Egypt

Individual Site Status

Completed

12. IPD Sharing Statement

Learn more about this trial

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

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