NCT06081335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

21 days

First QC Date

September 25, 2023

Last Update Submit

November 13, 2023

Conditions

Pain, PostoperativeIrreversible PulpitisApical Periodontitis

Keywords

painsubstance Pcontinuous rotationreciprocation

Outcome Measures

Primary Outcomes (2)

  • difference in substance P levels

    tested by radioimmunacy (ELISA)

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

  • 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

Study Arms (2)

Continuous Rotation group

ACTIVE COMPARATOR

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

Device: EdgeEndo x7 continuous rotation files

Reciprocation group

ACTIVE COMPARATOR

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

Device: EdgeOne Fire reciprocating files

Interventions

EdgeEndo x7 continuous rotation filesDEVICE

endodontic files operating in continuous rotation

Continuous Rotation group
EdgeOne Fire reciprocating filesDEVICE

endodontic files operating in reciprocating motion

Reciprocation group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ain Shams University

Cairo, Select A State Or Province, 11765, Egypt

Location

Ain Shams University

Cairo, 11765, Egypt

Location

Related Publications (1)

  • Abdel-Baset ST, Fahmy SH, Obeid MF. Can instrumentation kinematics affect postoperative pain and substance P levels? A randomized controlled trial. BMC Oral Health. 2024 Jan 17;24(1):102. doi: 10.1186/s12903-024-03882-x.

    PMID: 38233887DERIVED

MeSH Terms

Conditions

Pain, PostoperativePeriapical PeriodontitisPain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsPeriapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Officials

  • maram obeid

    professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 13, 2023

Study Start

March 15, 2023

Primary Completion

April 5, 2023

Study Completion

June 5, 2023

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations

EG(2)