- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05695053
Low Level Laser Therapy Applied in Orthodontic Tooth Movement
January 13, 2023 updated by: China Medical University Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jian-hong Yu, doctor
- Phone Number: +886 422053366
- Email: kenkoyu@mail.cmu.edu.tw
Study Contact Backup
- Name: CHUNYI HUANG, master
- Phone Number: +886 422053366
- Email: erichuangchunyi@gmail.com
Study Locations
-
-
-
Taichung City, Taiwan, 40402
- Recruiting
- China Medical University Hospital
-
Contact:
- Jian-hong Yu
- Phone Number: +886422053366
- Email: kenkoyu@mail.cmu.edu.tw
-
Contact:
- CHUNYI Huang
- Phone Number: +886422053366
- Email: erichuangchunyi@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with good oral hygiene, and over 18 years old, without serious medical history. Patients who required bilateral canine retraction into the extracted premolar sites were recruited.
Exclusion Criteria:
- (1) poor oral hygiene (2) previous orthodontic treatment (3) orthognathic surgery or syndromic patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: with LLLT
|
Low level laser therapy could provide energy to trigger cell differentiation.
|
Placebo Comparator: without LLLT
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Orthodontic tooth movement
Time Frame: 1-6month
|
the distance between canine and premolar
|
1-6month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bone density after Orthodontic tooth movement
Time Frame: 1-6month
|
bone density change around canine
|
1-6month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: SHENG-FEN HUANG, China Medical University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 27, 2021
Primary Completion (Actual)
August 26, 2022
Study Completion (Anticipated)
August 26, 2023
Study Registration Dates
First Submitted
January 13, 2023
First Submitted That Met QC Criteria
January 13, 2023
First Posted (Actual)
January 23, 2023
Study Record Updates
Last Update Posted (Actual)
January 23, 2023
Last Update Submitted That Met QC Criteria
January 13, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- CMUH110-REC2-138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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