Comparing Between XP Endo Finisher and Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth
Primary Purpose
Dental Pulp Necroses
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
XP Endo Finsher as final step of the irrigation protocol
Conventional needle irrigation only
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pulp Necroses
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
XP Endo Finisher
Conventional needle irrigation
Arm Description
Outcomes
Primary Outcome Measures
Post-operative pain recorded by the patient using a four step pain scale (0-3)
Secondary Outcome Measures
Post-operative swelling
Need\ number of Analgesic tablets
Need for systemic antibiotics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02952326
Brief Title
Comparing Between XP Endo Finisher and Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing the postoperative flare ups and pain after adding the XP Endo Finisher to the final irrigation protocol on necrotic mandibular premolars.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Necroses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XP Endo Finisher
Arm Type
Experimental
Arm Title
Conventional needle irrigation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
XP Endo Finsher as final step of the irrigation protocol
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Conventional needle irrigation only
Intervention Description
The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.
Primary Outcome Measure Information:
Title
Post-operative pain recorded by the patient using a four step pain scale (0-3)
Time Frame
up to 5 days after the treatment
Secondary Outcome Measure Information:
Title
Post-operative swelling
Time Frame
up to 5 days after the treatment
Title
Need\ number of Analgesic tablets
Time Frame
up to 5 days after the treatment
Title
Need for systemic antibiotics
Time Frame
up to 5 days after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27206916
Citation
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.
Results Reference
background
PubMed Identifier
12823700
Citation
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.
Results Reference
background
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Comparing Between XP Endo Finisher and Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth
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