NCT03023761

Brief Summary

In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain after irradiation of low level laser therapy

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
61

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable pain

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, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

January 11, 2017

Last Update Submit

January 17, 2017

Conditions

Pain

Keywords

Endodontic retreatmentsLow level laserPain

Outcome Measures

Primary Outcomes (1)

  • reduction of pain after low level laser irradiation

    baseline and 4, 8, 12, 24 and 48 hours after the treatment

Study Arms (2)

low level laser

ACTIVE COMPARATOR

A single visit Endodontic retreatment was done. After biomechanical preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the apices of the target tooth in the experimental group

Device: low level laser

laser sham

PLACEBO COMPARATOR

In the control group patients received placebo laser to eliminate the probable psychological effects of laser.

Device: laser sham

Interventions

low level laserDEVICE

low level laser irradiation

low level laser
laser shamDEVICE

laser without irradiation

laser sham

Eligibility Criteria

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

You may qualify if:

  • \- patients requiring endodontic retreatments in the posterior teeth

You may not qualify if:

  • systemic diseases psychologic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Beheshti University

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • mohammad asnaashari

    Shahid Beheshti University of Medical Sciences

    STUDY CHAIR

Central Study Contacts

saranaz azari-marhabi

CONTACT

09190129151saranazazari@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 18, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

IR(1)