NCT03096587

Brief Summary

Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single visit endodontic treatment and record postoperative pain afterwards.

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
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

March 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

April 15, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

March 25, 2017

Last Update Submit

August 21, 2017

Conditions

Symptomatic Irreversible Pulpitis

Keywords

XP Endo Finisherultrasonic activated irrigationpostoperative pain

Outcome Measures

Primary Outcomes (1)

  • post-operative pain

    measured by NRS (Numerical rate scale)

    up to 1 week after the visit

Secondary Outcomes (1)

  • Number of taken analgesic tablets

    within a week after the visit

Study Arms (2)

XP Endo Finisher file

EXPERIMENTAL

XP Endo Finisher file is used to activate irrigation as a final step in irrigation protocol

Device: XP Endo Finisher

ultrasonic activated irrigation

ACTIVE COMPARATOR

ultrasonic activated irrigation as a final step in irrigation protocol

Device: ultrasonic activated irrigation

Interventions

XP Endo FinisherDEVICE

a flexible single use NiTi file with small diameter and no taper, changes from straight M-phase to A-phase in body temperature

XP Endo Finisher file
ultrasonic activated irrigationDEVICE

by Satelec,Acteon, France

Also known as: Irrisafe
ultrasonic activated irrigation

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medically- free of any systemic disease
  • Male or female
  • Patients with age range 25-45
  • Symptomatic irreversible pulpitis in single rooted single canal teeth without apical periodontitis.
  • Teeth with mature root
  • Restorable teeth
  • Teeth without calcified root canals
  • Teeth without root caries
  • Teeth without internal or external root resorption
  • Teeth with no sign of crack formation
  • Teeth without anatomic abnormalities

You may not qualify if:

  • Pregnant females.
  • If analgesics have been administrated during the past two weeks preoperatively.
  • Patients having bruxism or clenching.
  • Multi rooted or multi canaled teeth.
  • Patients with swelling or acute peri-apical abscess.
  • Previously endodontically treated teeth
  • periodontally affected teeth .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and dental medicine, Cairo University

Cairo, Egypt

RECRUITING

Related Publications (3)

  • Alves FR, Andrade-Junior CV, Marceliano-Alves MF, Perez AR, Rocas IN, Versiani MA, Sousa-Neto MD, Provenzano JC, Siqueira JF Jr. Adjunctive Steps for Disinfection of the Mandibular Molar Root Canal System: A Correlative Bacteriologic, Micro-Computed Tomography, and Cryopulverization Approach. J Endod. 2016 Nov;42(11):1667-1672. doi: 10.1016/j.joen.2016.08.003. Epub 2016 Sep 15.

    PMID: 27641947RESULT

  • Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.

    PMID: 27248848RESULT

  • Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.

    PMID: 25598754RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Nouran A Hany, BDS

    Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

    PRINCIPAL INVESTIGATOR

  • Shaimaa I Gawdat, PHD

    Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

    STUDY DIRECTOR

  • Hebatallah M El-Far, Professor

    Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

    STUDY CHAIR

Central Study Contacts

Nouran A Hany, BDS

CONTACT

+2 01223626996nouranhany11@hotmail.com

Shaimaa I Gawdat, PHD

CONTACT

+2 01222235502shaimaagawdat@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patient will be blinded and will not know the group he is in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 25, 2017

First Posted

March 30, 2017

Study Start

April 15, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

EG(1)