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Bacteria Elimination in Retreatment Cases Using Different Disinfection Techniques

Primary Purpose

Root Canal Infection, Periapical; Infection

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
VDW Ultra
AMD picasso
ProtaperNext X3 gutta-percha
Sponsored by
Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Canal Infection focused on measuring photodynamic therapy, diode laser

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients with no clinical symptoms Endodontically treated teeth Single rooted teeth

Exclusion Criteria:

Teeth with fractured instrument, resorption, perforation, ledge, over fillings Periodontal pockets deeper than 4 mm

Sites / Locations

  • Bulent Ecevit University Faculty of Dentistry Department of Endodontics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Passive Ultrasonic irrigation

Manuel dynamic activation

Photodynamic Therapy

Arm Description

Irrigation solution was ultrasonically activated in the canal for 1 minute by using IrriSafe tip coupled to an ultrasonic device with VDW Ultra .

Irrigation solution was activated with a well-fitting a ProtaperNext X3 gutta-percha point placed to working length was then moved in push - pull motions at a rate of 100 strokes/per minute

Root canal was filled by 0.5 mL of 0.01% methylene blue (MB) solution for 5 minutes, then radiated by the light supply of a diode laser AMD picasso with a wavelength of 810 nm for 40 seconds (0.2 W).

Outcomes

Primary Outcome Measures

Bacteria change
Bacteria samples were taken at 3 step; before any intervention, after chemomechanical preparation, and after applying supplementary disinfection techniques

Secondary Outcome Measures

Full Information

First Posted
November 18, 2018
Last Updated
November 21, 2018
Sponsor
Bulent Ecevit University
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1. Study Identification

Unique Protocol Identification Number
NCT03750162
Brief Title
Bacteria Elimination in Retreatment Cases Using Different Disinfection Techniques
Official Title
Enterococcus Faecalis Elimination in Retreatment Cases Using Passive Ultrasonic Irrigation (PUI), Manual Dynamic Activation (MDA) and Photodynamic Therapy (PDT): a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
September 5, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Nonsurgical root canal retreatment may become essential when the initial endodontic treatment fails because of the persistent intracanal or extracanal infections.It has been stated that the one of the main cause of posttreatment disease is the persistent or reintroduced microorganism such as enterococcus faecalis. Supplementary disinfection techniques such as irrigation agitation methods can help elimination of bacteria from root canal systems. The aim of this in vivo study was to compare the effect of passive ultrasonic irrigation, manual dynamic activation and photodynamic therapy in reducing bacterial load in endodontic retreatment cases with periradicular lesion by using polymerase chain reaction (PCR)in a single visit root canal treatment.
Detailed Description
Thirty-six teeth with a single root and a single canal with posttreatment apical periodontitis which needed retreatment were selected for this study. Teeth were randomly divided into 3 groups according to the supplementary disinfection techniques used: Passive ultrasonic irrigation, Manual dynamic activation and Photodynamic therapy. Microbiological samples were taken before any intervention, after conventional chemo-mechanical preparation, and after disinfection techniques with sterile paper points and held in thioglycollate broth, and then were transferred to the microbiological laboratory. The amounts of e.faecalis in these samples was measured by using PCR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Infection, Periapical; Infection
Keywords
photodynamic therapy, diode laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive Ultrasonic irrigation
Arm Type
Experimental
Arm Description
Irrigation solution was ultrasonically activated in the canal for 1 minute by using IrriSafe tip coupled to an ultrasonic device with VDW Ultra .
Arm Title
Manuel dynamic activation
Arm Type
Experimental
Arm Description
Irrigation solution was activated with a well-fitting a ProtaperNext X3 gutta-percha point placed to working length was then moved in push - pull motions at a rate of 100 strokes/per minute
Arm Title
Photodynamic Therapy
Arm Type
Experimental
Arm Description
Root canal was filled by 0.5 mL of 0.01% methylene blue (MB) solution for 5 minutes, then radiated by the light supply of a diode laser AMD picasso with a wavelength of 810 nm for 40 seconds (0.2 W).
Intervention Type
Device
Intervention Name(s)
VDW Ultra
Intervention Description
supplementary disinfection technique
Intervention Type
Device
Intervention Name(s)
AMD picasso
Intervention Description
supplementary disinfection technique
Intervention Type
Device
Intervention Name(s)
ProtaperNext X3 gutta-percha
Intervention Description
supplementary disinfection technique
Primary Outcome Measure Information:
Title
Bacteria change
Description
Bacteria samples were taken at 3 step; before any intervention, after chemomechanical preparation, and after applying supplementary disinfection techniques
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with no clinical symptoms Endodontically treated teeth Single rooted teeth Exclusion Criteria: Teeth with fractured instrument, resorption, perforation, ledge, over fillings Periodontal pockets deeper than 4 mm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevinç Aktemur Türker
Organizational Affiliation
Bulent Ecevit University
Official's Role
Study Director
Facility Information:
Facility Name
Bulent Ecevit University Faculty of Dentistry Department of Endodontics
City
Zonguldak
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27330705
Citation
Asnaashari M, Godiny M, Azari-Marhabi S, Tabatabaei FS, Barati M. Comparison of the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy in Reducing the Microbial Flora of Root Canal in Endodontic Retreatment in Patients With Periradicular Lesions. J Lasers Med Sci. 2016 Spring;7(2):99-104. doi: 10.15171/jlms.2016.17. Epub 2016 Mar 27.
Results Reference
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PubMed Identifier
26234543
Citation
Rodrigues RC, Antunes HS, Neves MA, Siqueira JF Jr, Rocas IN. Infection Control in Retreatment Cases: In Vivo Antibacterial Effects of 2 Instrumentation Systems. J Endod. 2015 Oct;41(10):1600-5. doi: 10.1016/j.joen.2015.06.005. Epub 2015 Jul 30.
Results Reference
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Bacteria Elimination in Retreatment Cases Using Different Disinfection Techniques

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