Orthodontic Appliance ComplicationEarly Phase 1NCT05695053
Low Level Laser Therapy Applied in Orthodontic Tooth Movement
A Early Phase 1 study testing Low Level Laser Therapy in people with Orthodontic Appliance Complication, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Aug 2021to 26 Aug 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with good oral hygiene
- 18 years old
- Patients who required bilateral canine retraction into the extracted premolar
Who cannot join
- Serious medical history
- Poor oral hygiene
- Previous orthodontic treatment
- Orthognathic surgery or syndromic patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Low Level Laser Therapy, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
Low level laser therapy could provide energy to trigger cell differentiation.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| with LLLT | Experimental | Not described Receives: Device: Low Level Laser Therapy |
| without LLLT | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthodontic tooth movement
the distance between canine and premolar
Measured: 1-6month
Secondary outcomes (1)
bone density after Orthodontic tooth movement
bone density change around canine
Measured: 1-6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start27 Aug 2021
- Primary completion26 Aug 2022
- Study completion26 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SHENG-FEN HUANG, Study chair, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695053
- Sponsor's protocol ID
- CMUH110-REC2-138
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.
PubMed 25653800
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Therapy Applied in Orthodontic Tooth Movement
- ClinicalTrials.gov ID
- NCT05695053
- Acronym / sponsor ID
- CMUH110-REC2-138
- Conditions
- Orthodontic Appliance Complication
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2023 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with LLLT | Experimental | Device: Low Level Laser Therapy |
| without LLLT | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with good oral hygiene
- 18 years old
- Patients who required bilateral canine retraction into the extracted premolar
Key exclusion criteria (4 listed)
- Serious medical history
- Poor oral hygiene
- Previous orthodontic treatment
- Orthognathic surgery or syndromic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser TherapyLow level laser therapy could provide energy to trigger cell differentiation. | Device | with LLLT |
| PlaceboPlacebo | Other | without LLLT |
Primary outcome
Orthodontic tooth movement
Time frame: 1-6month
the distance between canine and premolar
1 secondary outcome
bone density after Orthodontic tooth movement
Time frame: 1-6month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Results publication: PubMed 25653800Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.
- Individual participant dataSharing planned: Undecided
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The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
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Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SHENG-FEN HUANG study chair
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low Level Laser Therapy in people with Orthodontic Appliance Complication, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthodontic tooth movement (time frame: 1-6month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05695053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.