NCT05695053

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Aug 2021

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

August 27, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2023

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

January 13, 2023

Last Update Submit

February 11, 2025

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

  • Orthodontic tooth movement

    the distance between canine and premolar

    1-6month

Secondary Outcomes (1)

  • bone density after Orthodontic tooth movement

    1-6month

Study Arms (2)

with LLLT

EXPERIMENTAL
Device: Low Level Laser Therapy

without LLLT

PLACEBO COMPARATOR
Other: Placebo

Interventions

Low Level Laser TherapyDEVICE

Low level laser therapy could provide energy to trigger cell differentiation.

with LLLT
PlaceboOTHER

Placebo

without LLLT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 40402, Taiwan

Location

Related Publications (1)

  • Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.

    PMID: 25653800RESULT

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • SHENG-FEN HUANG

    China Medical University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 23, 2023

Study Start

August 27, 2021

Primary Completion

August 26, 2022

Study Completion

August 26, 2023

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations

TW(1)