Management of Post Endodontic Re-treatment Pain With Low-... | NCT03023761

Studies
Management of Post Endodontic Re-treatment Pain With Low-Level Laser Therapy

NCT03023761

Sponsor

Shahid Beheshti University

Status

Unknown status

Last Update Posted

Jan 18, 2017Estimated

Enrollment

61Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

low level laser
laser sham

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Mar 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Jan 11, 2017

First Submission Date that Met QC Criteria

Jan 17, 2017

First Posted Date

Jan 18, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

saranaz azari-marhabi, assistant professor, Shahid Beheshti UniversityPrincipal Investigator

Lead Sponsor

Shahid Beheshti UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

In this clinical trial, 61 patients requiring endodontic retreatments in the posterior teeth were selected. 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. In the control group patients received placebo laser to eliminate the probable psychological effects of laser. Laser irradiation was done with a single dose of 808 nm wavelength (Whitening Lase II- Laser DMC, Samsung, Korea) with 100 mw power, and dose of 70 J/cm2 for 80 seconds. Pain severity was recorded before the treatment, immediately after the treatment and 4, 8, 12, 24 and 48 hours after the treatment by visual analogue scale (VAS). The pain scores were statistically analyzed by chi-square test between two groups. The effects of different variables on the post-operative pain experience were also studied by means of Logistic regression.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
low level laser	Device	low level laser irradiation	low level laser

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction of pain after low level laser irradiation		baseline and 4, 8, 12, 24 and 48 hours after the treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- patients requiring endodontic retreatments in the posterior teeth

Exclusion Criteria:

systemic diseases psychologic disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
saranaz azari-marhabi	Contact	09190129151		saranazazari@yahoo.com

Overall Officials

Name	Affiliation	Role
mohammad asnaashari	Shahid Beheshti University of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shahid Beheshti University	Recruiting	Tehran			Iran

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D028022	Low-Level Light Therapy

Ancestor Terms

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D010789	Phototherapy

Browse Leaves

Not provided

Browse Branches

Not provided