NCT03285334

Brief Summary

enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed consent. allocation of the patient to either intervention or control group. After anaesthesia and access cavity, the first root canal sample will be taken. Endodontic treatment will be completed in one visit. The second root canal sample will be taken. Patients will be asked to evaluate their postoperative pain level using VAS scale at 6, 12, 24 hours, and daily up to 5 days. Patients will record the number of analgesics if any taken.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

September 13, 2017

Last Update Submit

September 14, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    Degree of postoperative pain will be measured by the patients using modified VAS

    up to 5 days

Secondary Outcomes (2)

  • intracanal bacterial reduction

    6 hours

  • Incidence of analgesic intake

    up to 5 days

Study Arms (2)

XP-endo Shaper

EXPERIMENTAL

The XP-endo Shaper is an innovative single instrument manufactured from Max wire. Its special ability to shift crystalline structure at body temperature in order to adapt to the root canal wall, has provided a unique instrument with the promise of anatomical shaping.

Device: XP-endo Shaper

iRace

ACTIVE COMPARATOR

rotary files

Device: iRace files

Interventions

XP-endo ShaperDEVICE

mechanical preparation in a 3D manner using Xp-endo Shaper

Also known as: anatomical (3D) shaping file
XP-endo Shaper
iRace filesDEVICE

rotary mechanical preparation

Also known as: rotary files
iRace

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Adult patients.
  • Age between 20-40 years old.
  • Males \& Females.
  • Asymptomatic necrotic mandibular premolars with or without periapical radiolucency.
  • Normal occlusal contact with the opposing teeth.
  • Patients accepting to participate in the study.

You may not qualify if:

  • Medically compromised patients
  • Pregnant women
  • If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively
  • Patients reporting bruxism or clenching
  • Teeth that shows:
  • Association with acute periapical abscess and swelling
  • Greater than grade I mobility or pocket depth greater than 5mm
  • No restorability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine - Cairo University

Cairo, Manial, 11553, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Radwa Emara

    faculty of oral and dental medicine - cairo university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

radwa emara

CONTACT

01272141312radwa.emara@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
* The patients will drag an envelope and will not know to which group they will be assigned. * The patients who already do not know their treatment group will assess the level of their post-operative pain and will record the number of analgesic tablets used. * The laboratory technician at the microbiological department will not know the treatment group of the patients.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 18, 2017

Study Start

November 1, 2017

Primary Completion

February 1, 2018

Study Completion

November 1, 2018

Last Updated

September 18, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)