Comparing Between XP Endo Finisher and Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth

November 14, 2016 updated by: Ghada Ihab Mohamed, Cairo University

Comparison Of The Effect of Adding XP Endo Finisher To The Irrigation Protocol Versus Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth

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

Study Overview

Detailed Description

patients are randomized into 2 groups after meeting the eligibility criteria,

  1. Each patient will be given pain scale chart in order to record his /her pain level before any intervention.
  2. The tooth is anesthetized, accessed and mechanical instrumentation to be made 3 A) For the experimental group: 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

B) For the control group :

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

4) Obturation is done and postoperative instructions are given to the patient

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XP Endo Finisher
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
Active Comparator: Conventional needle irrigation
The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-operative pain recorded by the patient using a four step pain scale (0-3)
Time Frame: up to 5 days after the treatment
up to 5 days after the treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-operative swelling
Time Frame: up to 5 days after the treatment
up to 5 days after the treatment
Need\ number of Analgesic tablets
Time Frame: up to 5 days after the treatment
up to 5 days after the treatment
Need for systemic antibiotics
Time Frame: up to 5 days after the treatment
up to 5 days after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • XP and Protaper next

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Pulp Necroses

3
Subscribe