NCT02952326

Brief Summary

Comparing the postoperative flare ups and pain after adding the XP Endo Finisher to the final irrigation protocol on necrotic mandibular premolars.

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
34

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

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

October 31, 2016

Last Update Submit

November 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain recorded by the patient using a four step pain scale (0-3)

    up to 5 days after the treatment

Secondary Outcomes (3)

  • Post-operative swelling

    up to 5 days after the treatment

  • Need\ number of Analgesic tablets

    up to 5 days after the treatment

  • Need for systemic antibiotics

    up to 5 days after the treatment

Study Arms (2)

XP Endo Finisher

EXPERIMENTAL
Procedure: XP Endo Finsher as final step of the irrigation protocol

Conventional needle irrigation

ACTIVE COMPARATOR
Procedure: Conventional needle irrigation only

Interventions

The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. XP Endo finisher is used after the last instrument in preparation

XP Endo Finisher

The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.

Conventional needle irrigation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • i. Age between 18-50 years old. ii. Males or Females. iii. mandibular Premolars
  • Asymptomatic.
  • Non-vital response of pulp tissue (negative response).
  • With or without periapical radiolucency.

You may not qualify if:

  • i. Patients allergic to penicillin. ii. Pregnant females. iii. Patients having significant systemic disorder. iv. If antibiotics have been administrated during the past two weeks preoperatively.
  • v. Patients having bruxism or clenching. vi. Teeth that have :
  • Vital pulp tissues.
  • Association with swelling
  • Acute peri-apical abscess
  • Periodontally affected teeth
  • No possible restorability
  • Previous endodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Elnaghy AM, Mandorah A, Elsaka SE. Effectiveness of XP-endo Finisher, EndoActivator, and File agitation on debris and smear layer removal in curved root canals: a comparative study. Odontology. 2017 Apr;105(2):178-183. doi: 10.1007/s10266-016-0251-8. Epub 2016 May 20.

    PMID: 27206916BACKGROUND
  • Siqueira JF Jr. Microbial causes of endodontic flare-ups. Int Endod J. 2003 Jul;36(7):453-63. doi: 10.1046/j.1365-2591.2003.00671.x.

    PMID: 12823700BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Endodontic department, faculty of oral and dental medicine

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

December 1, 2016

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share