NCT03750162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

November 18, 2018

Last Update Submit

November 21, 2018

Conditions

Root Canal InfectionPeriapical; Infection

Keywords

photodynamic therapydiode laser

Outcome Measures

Primary Outcomes (1)

  • Bacteria change

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

    1 year

Study Arms (3)

Passive Ultrasonic irrigation

EXPERIMENTAL

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

Device: VDW Ultra

Manuel dynamic activation

EXPERIMENTAL

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

Device: ProtaperNext X3 gutta-percha

Photodynamic Therapy

EXPERIMENTAL

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).

Device: AMD picasso

Interventions

VDW UltraDEVICE

supplementary disinfection technique

Passive Ultrasonic irrigation
AMD picassoDEVICE

supplementary disinfection technique

Photodynamic Therapy
ProtaperNext X3 gutta-perchaDEVICE

supplementary disinfection technique

Manuel dynamic activation

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with no clinical symptoms Endodontically treated teeth Single rooted teeth

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bulent Ecevit University Faculty of Dentistry Department of Endodontics

Zonguldak, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 27330705BACKGROUND

  • 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.

    PMID: 26234543BACKGROUND

MeSH Terms

Conditions

Infections

Study Officials

  • Sevinç Aktemur Türker

    Bulent Ecevit University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 18, 2018

First Posted

November 21, 2018

Study Start

February 1, 2017

Primary Completion

June 15, 2017

Study Completion

September 5, 2017

Last Updated

November 23, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)