NCT02555488

Brief Summary

The aim of this study was to compare the Antibacterial Efficacy of Diode Laser 810nm and Photodynamic therapy in reducing bacterial microflora in endodontic retreatment of teeth with periradicular lesion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

September 15, 2015

Last Update Submit

September 18, 2015

Conditions

Periradicular Disease

Outcome Measures

Primary Outcomes (1)

  • bacterial colony forming unit(CFU/ML)

    after doing protocol in each groups CFU /ml for different bacteria will be counted

    12 months

Study Arms (2)

2

EXPERIMENTAL

in the second group diode laser (810 nm, 1.2 W, 30 s) was irradiated. Then second samples were taken from all canals.

Device: diode laser

1

EXPERIMENTAL

In the first group Photodynamic therapy (PDT) with Methylene blue and diode laser (810 nm, 0.2 W, 40 second) was done

Device: diode laserDrug: Methylene blue

Interventions

diode laserDEVICE

MB and diode

1
Methylene blueDRUG

Methylene blue and diode laser was used

1

Eligibility Criteria

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

You may qualify if:

  • \- endodontic retreatment of teeth with periradicular lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Beheshti University

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Periapical Diseases

Interventions

Lasers, SemiconductorMethylene Blue

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and SuppliesPhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • saranaz azari-marhabi, DMD

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

saranaz azari-marhabi, DMD

CONTACT

09190129151saranazazari@yahoo.com

mohammad asnaashari, DMD

CONTACT

09190129151mo_asna@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 21, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

September 21, 2015

Record last verified: 2015-09

Locations

IR(1)