Crowding of Anterior Maxillary TeethNCT06493721
Clear Aligner Treatment With and Without Low Level Laser Therapy for Upper Incisor Crowding
A study testing Clear Aligner Treatment and Low level laser in people with Crowding of Anterior Maxillary Teeth, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess the effect of Low Level Laser Therapy (LLLT) on Upper Incisor Crowding using Clear Aligner Treatment (CAT). Read more about this study
- Who is it for?
- Ages 16 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Crowding of Anterior Maxillary Teeth
- What is being tested?
- Clear Aligner Treatment and Low level laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 28 Jun 2024
- Phase
- Interventional
- 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 16 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients age ranging from 16-23 years old with Angle class I malocclusion and upper anterior crowding.
- Healthy, compliant and internally motivated patient.
- Full set of maxillary permanent dentition except third molar.
Who cannot join
- Previous orthodontic treatment.
- Any systemic diseases that could interfere with orthodontic treatment.
- Gross gingival or periodontal problems
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine for Girls Al-Azhar University
Cairo, 11787
About this study
Official title: Clear Aligner Treatment for Upper Incisor Crowding With Low-Level Laser Therapy: A Comparative Clinical Study
The goal of this clinical trial is to assess the effect of Low Level Laser Therapy (LLLT) on Upper Incisor Crowding using Clear Aligner Treatment (CAT).
Read the detailed description
The goal of this clinical trial is to assess the effect of Low Level Laser Therapy (LLLT) on Upper Incisor Crowding using Clear Aligner Treatment (CAT) on healthy patients (16-23 years old) with complete set of dentition and Angle class I. The main questions to answer are:
- Evaluate rate of Upper Incisor Decrowding using CAT and LLLT
- Does LLLT affect pain during CAT?
Researchers will compare CAT with LLLT to CAT without LLLT to see if the LLLT will accelerate Orthodontic Tooth Movement.
Participants will:
- Change to a new aligner every 7 days.
- Visit the clinic every week for checkup.
- Log in pain scores every 6, 24, 48 and 72 hours after delivery of new aligners.
- Conditions
- Crowding of Anterior Maxillary Teeth
- Being tested
- Clear Aligner Treatment, Low level laser
- Keywords
- Clear aligner treatment, Low level laser therapy, Clear aligner therapy, Accelerated orthodontics, orthodontic tooth movement, upper incisor crowding, orthodontic pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear Aligner TreatmentProcedure or surgery
Clear aligner therapy to treat incisors crowding
Low level laserProcedure or surgery
Apply clear aligner therapy with low level laser application on incisors
| Study group | Role | What they receive |
|---|---|---|
| Clear aligner only | Experimental | Clear aligner therapy group only Receives: Procedure: Clear Aligner Treatment |
| Low level laser | Experimental | Clear aligner therapy with low level laser therapy Receives: Procedure: Clear Aligner Treatment; Procedure: Low level laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of tooth movement
Calculate rate of anterior incisor decrowding using digital measurement in millimetre
Measured: Initial alignment at the end of 3rd month during treatment planning of clear aligner
Secondary outcomes (1)
Pain level
Will Low Level Laser Therapy decrease pain levels during clear aligner treatment. Evaluated using Numerical Rating Scale
Measured: Initial alignment at the end of 3rd month phase during treatment planning of clear aligner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start15 Dec 2022
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crowding of Anterior Maxillary TeethStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nada Ashraf Ali, Faculty of Dental Medicine for Girls
- Investigators
- Samir Abdo, Study director, Faculty of Dental Medicine, Girls Branch, Al Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493721
- Sponsor's protocol ID
- ORTHO-109-2-M
- Status last verified
- Jul 2024
- First submitted
- 29 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clear Aligner Treatment for Upper Incisor Crowding With Low-Level Laser Therapy: A Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT06493721
- Acronym / sponsor ID
- ORTHO-109-2-M
- Conditions
- Crowding of Anterior Maxillary Teeth
- Keywords
- Clear aligner treatment, Low level laser therapy, Clear aligner therapy, Accelerated orthodontics, orthodontic tooth movement, upper incisor crowding, orthodontic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 10 Jul 2024 (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.
The goal of this clinical trial is to assess the effect of Low Level Laser Therapy (LLLT) on Upper Incisor Crowding using Clear Aligner Treatment (CAT).
Detailed description
The goal of this clinical trial is to assess the effect of Low Level Laser Therapy (LLLT) on Upper Incisor Crowding using Clear Aligner Treatment (CAT) on healthy patients (16-23 years old) with complete set of dentition and Angle class I. The main questions to answer are:
- Evaluate rate of Upper Incisor Decrowding using CAT and LLLT
- Does LLLT affect pain during CAT?
Researchers will compare CAT with LLLT to CAT without LLLT to see if the LLLT will accelerate Orthodontic Tooth Movement.
Participants will:
- Change to a new aligner every 7 days.
- Visit the clinic every week for checkup.
- Log in pain scores every 6, 24, 48 and 72 hours after delivery of new aligners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear aligner only | Experimental | Procedure: Clear Aligner TreatmentClear aligner therapy group only |
| Low level laser | Experimental | Procedure: Clear Aligner Treatment, Procedure: Low level laserClear aligner therapy with low level laser therapy |
Who may qualify
- Ages
- 16 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients age ranging from 16-23 years old with Angle class I malocclusion and upper anterior crowding.
- Healthy, compliant and internally motivated patient.
- Full set of maxillary permanent dentition except third molar.
Key exclusion criteria (3 listed)
- Previous orthodontic treatment.
- Any systemic diseases that could interfere with orthodontic treatment.
- Gross gingival or periodontal problems
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 |
|---|---|---|
| Clear Aligner TreatmentClear aligner therapy to treat incisors crowding | Procedure or surgery | Clear aligner only, Low level laser |
| Low level laserApply clear aligner therapy with low level laser application on incisors | Procedure or surgery | Low level laser |
Primary outcome
Rate of tooth movement
Time frame: Initial alignment at the end of 3rd month during treatment planning of clear aligner
Calculate rate of anterior incisor decrowding using digital measurement in millimetre
1 secondary outcome
Pain level
Time frame: Initial alignment at the end of 3rd month phase during treatment planning of clear aligner
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 10 Jul 2024.
Related trials for Crowding of Anterior Maxillary Teeth
Recruiting
Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition
Crowding of Anterior Maxillary Teeth, Orthodontics, Interceptive
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.
Samir Abdo study director
Faculty of Dental Medicine, Girls Branch, Al Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Aligner Treatment and Low level laser in people with Crowding of Anterior Maxillary Teeth, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
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 3 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 10 Jul 2024. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Rate of tooth movement (time frame: Initial alignment at the end of 3rd month during treatment planning of clear aligner). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2024.