NCT05653947

Brief Summary

This clinical study aimed to Compare the levels of Interleukin 8 before and after root canal treatment in patients with apical periodontitis

  • Diagnosis
  • Local anesthesia
  • Isolation and disinfection of the tooth
  • Two-staged access cavity preparation
  • Patency of the root canals
  • First sample collection using paper points
  • Working length determination
  • Chemico-mechanical preparation
  • After 1 week, isolation, Second sample collection then obturation of the root canals and restoration of the tooth.
  • Samples will be stored in (-80 C) freezer till collection of all samples then, quantification will be done using ELISA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

November 27, 2022

Last Update Submit

January 18, 2023

Conditions

Apical Periodontitis

Keywords

interleukin 8apical periodontitis

Outcome Measures

Primary Outcomes (1)

  • interleukin 8

    Cytokine expression of IL8

    immediately after access cavity preparation and immediately after root canal instrumentation

Study Arms (2)

Vital teeth

EXPERIMENTAL

root canal instrumentation sodium hypochlorite 2.5% irrigation

Procedure: Root canal instrumentation, 2.5% NaOCl irrigation

Non-vital teeth

OTHER

root canal instrumentation sodium hypochlorite 2.5% irrigation

Procedure: Root canal instrumentation, 2.5% NaOCl irrigation

Interventions

Root canal instrumentation, 2.5% NaOCl irrigationPROCEDURE

Root canal instrumentation, 2.5% NaOCl irrigation

Non-vital teethVital teeth

Eligibility Criteria

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

You may qualify if:

  • Medically free patients
  • Single canaled teeth diagnosed clinically with symptomatic apical periodontitis.
  • Radiographic widening in the periodontal membrane space.
  • Presence of pain on percussion.
  • Patients' acceptance to participate in the trial.

You may not qualify if:

  • Medically compromised patients.
  • Pregnant women: Avoid radiation exposure, anesthesia, and medication.
  • If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
  • Teeth that shows association with acute periapical abscess or swelling: Need special treatment steps which could involve additional visits with incision and drainage.
  • Presence of periodontal disease
  • Non restorability
  • Immature teeth
  • Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Endodontics

Study Record Dates

First Submitted

November 27, 2022

First Posted

December 16, 2022

Study Start

March 10, 2022

Primary Completion

July 30, 2022

Study Completion

November 25, 2022

Last Updated

January 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)