NCT02984488

Brief Summary

To evaluate the incidence and severity of postoperative pain after root canal therapy of necrotic teeth in one appointment versus two appointments using Protaper next instrument.

Trial Health

35
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 P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

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

November 14, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

December 7, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

November 14, 2016

Last Update Submit

December 6, 2016

Conditions

Keywords

necrotic teethsingle visitmultiple visitsprotaper next

Outcome Measures

Primary Outcomes (1)

  • Change of post operative pain.

    After 6-12-24-48 hours from the obturation step of the endodontic treatment.

Study Arms (2)

single visit endodontic treatment.

EXPERIMENTAL

•single visit endodontic Treatment of necrotic teeth using Protaper next.

Procedure: single visits

Two visits endodontic treatment

ACTIVE COMPARATOR

•Two visits endodontic Treatment of necrotic teeth using Protaper next.

Procedure: two visits

Interventions

single visitsPROCEDURE

Endodontic treatment is done and completed in a single visit using protaper next rotary system.

single visit endodontic treatment.
two visitsPROCEDURE

Endodontic treatment is done and completed in two visits using protaper next rotary system.

Two visits endodontic treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medically free patients.
  • Patient's age above 18 years old.
  • Teeth diagnosed clinically with necrosis.
  • Positive patient's acceptance for participation in the study.
  • Sex includes both male and female.
  • Patients who can understand visual analogue scale.
  • Patients able to sign informed consent.

You may not qualify if:

  • Pregnancy or lactation.
  • Medically compromised patients.
  • Patient with multiple teeth that required treatment in the same quadrant to eliminate the possibility of pain referral.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Rao KN, Kandaswamy R, Umashetty G, Rathore VP, Hotkar C, Patil BS. Post-Obturation pain following one-visit and two-visit root canal treatment in necrotic anterior teeth. J Int Oral Health. 2014 Apr;6(2):28-32. Epub 2014 Apr 26.

    PMID: 24876699BACKGROUND
  • DiRenzo A, Gresla T, Johnson BR, Rogers M, Tucker D, BeGole EA. Postoperative pain after 1- and 2-visit root canal therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 May;93(5):605-10. doi: 10.1067/moe.2002.121900.

    PMID: 12075212BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Saeed M Abd El aziz, professor

    Department of endodontics - Faculty of Oral and Dental medicine - CU

    STUDY CHAIR
  • hebatallah M nada, student

    Department of endodontics - Faculty of Oral and Dental medicine - CU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hebatallah M nada, student

CONTACT

Abeer sabi, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 14, 2016

First Posted

December 7, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

December 7, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share