Low Level Laser Therapy Applied in Orthodontic Tooth Move... | NCT05695053

Studies
Low Level Laser Therapy Applied in Orthodontic Tooth Movement

NCT05695053

Sponsor

China Medical University Hospital

Status

Completed

Last Update Posted

Feb 13, 2025Actual

Enrollment

20Actual

Phase

Early Phase 1

Conditions

Orthodontic Appliance Complication

Interventions

Low Level Laser Therapy
Placebo

Countries

Taiwan

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

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 27, 2021Actual

Primary Completion Date

Aug 26, 2022Actual

Completion Date

Aug 26, 2023Actual

First Submitted Date

Jan 13, 2023

First Submission Date that Met QC Criteria

Jan 13, 2023

First Posted Date

Jan 23, 2023Actual

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

Feb 11, 2025

Last Update Posted Date

Feb 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Currently, orthodontic treatment takes 2-3 years.. If we accelerate tooth movement by low energy laser therapy, we could reduce treatment time. Low Level Laser Therapy(LLLT) applied in Orthodontic Tooth Movement, which stimulates formation of osteoclast-like cells expression in vitro. Osteoclast can be served as an index for tooth movement. Increasing the number of osteoclast will increase bone formation and tooth movement. We plan to find a useful clinical protocol to improve the efficiency of orthodontic tooth movement. Test low energy laser in vitro. Find an effective wavelength and irradiation time to stimulate formation of osteoclast. Develop an useful protocol that clinical orthodontist could follow and reduce orthodontic treatment time.

Detailed Description

Not provided

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
with LLLT	Experimental		Device: Low Level Laser Therapy
without LLLT	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low Level Laser Therapy	Device	Low level laser therapy could provide energy to trigger cell differentiation.	with LLLT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Orthodontic tooth movement	the distance between canine and premolar	1-6month

Secondary Outcomes

Measure	Description	Time Frame
bone density after Orthodontic tooth movement	bone density change around canine	1-6month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with good oral hygiene
18 years old
Patients who required bilateral canine retraction into the extracted premolar

Exclusion Criteria:

Serious medical history
Poor oral hygiene
Previous orthodontic treatment
Orthognathic surgery or syndromic patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
SHENG-FEN HUANG	China Medical University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University Hospital		Taichung		40402	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25653800	Result	Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D010789	Phototherapy