- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02952326
Comparing Between XP Endo Finisher and Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth
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
Study Overview
Status
Conditions
Detailed Description
patients are randomized into 2 groups after meeting the eligibility criteria,
- Each patient will be given pain scale chart in order to record his /her pain level before any intervention.
- 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
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XP and Protaper next
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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