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Effect of Removal of Double Antibiotic Paste on Post Operative Pain

Primary Purpose

Effects of the Elements

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
double antibiotic paste with XP-endo Finisher file
double antibiotic paste with Irrisafe Ultrasonic tip
double antibiotic paste with side vented needle
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effects of the Elements

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Medically free patients.
  • Patient's age between 20-50 years.
  • Both sexes.
  • Necrotic pulp as indicated by thermal or electric pulp testing.
  • No history of previous endodontic treatment of the tooth.
  • Enough crown structure for adequate isolation.

Exclusion Criteria:

  • Pregnancy or lactation
  • Medically compromised patients
  • Previous endodontic therapy of the affected tooth.
  • Teeth diagnosed with vital pulp.
  • Teeth with periodontal pocket more than 3mm deep.
  • Teeth with abnormal anatomy or calcified canals.
  • Teeth with caries below the bony level (non-restorable tooth).
  • Immature teeth with open apices.

Sites / Locations

  • Faculty of Oral and dental medicine, Minia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

XP-endo Finisher file

Irrisafe Ultrasonic tip

side vented needle

Arm Description

removal of double antibiotic paste intracanal medication with XP-endo Finisher file

removal of double antibiotic paste intracanal medication with passive ultrasonic irrigation

removal of double antibiotic paste intracanal medication with conventional syringe irrigation

Outcomes

Primary Outcome Measures

change in post operative pain (Visual Analogue Scale)
Numerical (0-10)

Secondary Outcome Measures

Full Information

First Posted
March 27, 2020
Last Updated
April 5, 2020
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04327453
Brief Title
Effect of Removal of Double Antibiotic Paste on Post Operative Pain
Official Title
Influence of Different Methods of Removal of Double Antibiotic Paste as an Intracanal Medication on Post Operative Pain:a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Recruited patients with necrotic pulp after application of double antibiotic paste are assigned to group (XP Endo Finisher file) and group( Passive ultrasonic irrigation) and group (conventional syringe irrigation with side vented needle) to remove intracanal medication and record postoperative pain afterwards.
Detailed Description
The investigator will recruit patients who are found eligible to the criteria, double antibiotic paste will be inserted inside the canals. After 7 days, patients will be randomly assigned to either removal of intracanal medication using, the XP-Endo Finisher file, passive ultrasonic irrigation (PUI) and conventional syringe irrigation with side vented needle. After the visit, patients will be asked to record post operative pain by Visual Analog Scale)in a given sheet

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effects of the Elements

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XP-endo Finisher file
Arm Type
Experimental
Arm Description
removal of double antibiotic paste intracanal medication with XP-endo Finisher file
Arm Title
Irrisafe Ultrasonic tip
Arm Type
Experimental
Arm Description
removal of double antibiotic paste intracanal medication with passive ultrasonic irrigation
Arm Title
side vented needle
Arm Type
Active Comparator
Arm Description
removal of double antibiotic paste intracanal medication with conventional syringe irrigation
Intervention Type
Device
Intervention Name(s)
double antibiotic paste with XP-endo Finisher file
Intervention Description
XP-endo Finisher files (FKG Dentaire, La Chaux-de-Fonds, Switzerland). file will be used with an endodontic motor X-Smart (Dentsply Sirona, Ballaigues, Switzerland) in removal of double antibiotic paste
Intervention Type
Device
Intervention Name(s)
double antibiotic paste with Irrisafe Ultrasonic tip
Other Intervention Name(s)
passive ultrasonic irrigation
Intervention Description
passive ultrasonic irrigation (PUI) with an IrriSafe Ultrasonic tips (Acteon,France), which will be driven by an ultrasonic device (Newtron P5, Satelec, Acteongroup, Merignac, France) in removal of double antibiotic paste
Intervention Type
Device
Intervention Name(s)
double antibiotic paste with side vented needle
Other Intervention Name(s)
conventional syringe irrigation
Intervention Description
conventional syringe irrigation with side vented needle (prime Dent, India) in removal of double antibiotic paste
Primary Outcome Measure Information:
Title
change in post operative pain (Visual Analogue Scale)
Description
Numerical (0-10)
Time Frame
Intrappointment at 4,24,48,72 and 96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Medically free patients. Patient's age between 20-50 years. Both sexes. Necrotic pulp as indicated by thermal or electric pulp testing. No history of previous endodontic treatment of the tooth. Enough crown structure for adequate isolation. Exclusion Criteria: Pregnancy or lactation Medically compromised patients Previous endodontic therapy of the affected tooth. Teeth diagnosed with vital pulp. Teeth with periodontal pocket more than 3mm deep. Teeth with abnormal anatomy or calcified canals. Teeth with caries below the bony level (non-restorable tooth). Immature teeth with open apices.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaimaa Nasr El-din Abd El-Ghaffar, MsC
Phone
+0201020271788
Email
dr_shimes@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Reham Hassan, Ass.prof
Phone
+0201001542529
Email
reham-hassan@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdy Mohamed Ali, Professor
Organizational Affiliation
Dean of faculty
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Oral and dental medicine, Minia University
City
Minya
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaimaa Nasr El-deen, PHD
Phone
+0201020271788
Email
dr_shimes@hotmail.com
First Name & Middle Initial & Last Name & Degree
Shaimaa El-Gaffar, PHD

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
23657409
Citation
Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
Results Reference
background
PubMed Identifier
20647083
Citation
Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
Results Reference
result
PubMed Identifier
25598754
Citation
Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.
Results Reference
result

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Effect of Removal of Double Antibiotic Paste on Post Operative Pain

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