This Study Focus on the Effect of Low-Level Light Therapy on the Amount of Upper Molar DistalizationLLLTNCT06170099
Assessment of Low Level Laser Therapy Effect on Treatment Outcomes of Bony Supported Distal Jet for Correction of Angle Class II Malocclusion (Randomized Clinical Trial)
A study testing low level laser therapy and bonny supported distal jet in people with This Study Focus on the Effect of Low-Level Light Therapy on the Amount of Upper Molar Distalization, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to compare the effect of LLLT in adolescent patient with class II malocclusion. The main question it aims to answer is: is there a difference in the amount of distalization between laser and control groups? Participants will received bony supported distal jet. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- This Study Focus on the Effect of Low-Level Light Therapy on the Amount of Upper Molar Distalization
- What is being tested?
- low level laser therapy and bonny supported distal jet
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2020to Mar 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- bilateral Angle's Class II malocclusion minimum of 1/4 cusp discrepancy, normal or low mandibular plane (MP) angle cases and no history of serious medical illness
Who cannot join
- subjects with skeletal Class II with retrusion mandibular profile, vertical growth pattern and steep mandibular plane angle and subjects with shallow or anterior open bite.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al Azhar dental hospital
Cairo, Nasr City, 002
Rabab HF elhossieni, MSD, 01143376466, dr.rababelhosseny@yahoo.com
Rabab HF elhossieni, MSD
About this study
The goal of this randomized clinical trial is to compare the effect of LLLT in adolescent patient with class II malocclusion. The main question it aims to answer is:
- is there a difference in the amount of distalization between laser and control groups? Participants will received bony supported distal jet. Researchers will compare laser group with control group to see if there is a difference in amount of distalization between groups.
Read the detailed description
The aim of the present study is to assess the effect of low level laser therapy on treatment outcomes of bony supported distal jet for correction of 20 orthodontic patients with angle class II malocclusion. enrolled patient is randomly divided into 2 groups laser group and distal screw group. for result assessment dental casts and CBCT are taken before and after completion of distalization. both groups receives Distal Jet supported on 2 paramedian screw with laser therapy for laser group only.
- Conditions
- This Study Focus on the Effect of Low-Level Light Therapy on the Amount of Upper Molar Distalization
- Being tested
- low level laser therapy, bonny supported distal jet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyRadiation
irradiation with LLLT by the following regimen 0, 3, 7 and 14 from the activation of the bony supported Distal Jet and then every 15 days till completion of distalization
bonny supported distal jetDevice
distal jet distalizing appliance is supported on two paramedian screw
| Study group | Role | What they receive |
|---|---|---|
| Laser group | Experimental | Not described Receives: Radiation: low level laser therapy; Device: bonny supported distal jet |
| control group | Active comparator | Not described Receives: Device: bonny supported distal jet |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of upper first molar distal movement
mm/month
Measured: till achievement of class I molar relation, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start20 Feb 2020
- Primary completionJan 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Focus on the Effect of Low-Level Light Therapy on the Amount of Upper Molar DistalizationStudies 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
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rabab Abdel Hafez El Hosseini, Al-Azhar University
- Investigators
- Rabab HF elhosseini, MSD, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170099
- Sponsor's protocol ID
- REC-OR-19-01
- Acronym
- LLLT
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Low Level Laser Therapy Effect on Treatment Outcomes of Bony Supported Distal Jet for Correction of Angle Class II Malocclusion (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06170099
- Acronym / sponsor ID
- LLLT / REC-OR-19-01
- Conditions
- This Study Focus on the Effect of Low-Level Light Therapy on the Amount of Upper Molar Distalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 14 Dec 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.
The goal of this randomized clinical trial is to compare the effect of LLLT in adolescent patient with class II malocclusion. The main question it aims to answer is:
- is there a difference in the amount of distalization between laser and control groups? Participants will received bony supported distal jet. Researchers will compare laser group with control group to see if there is a difference in amount of distalization between groups.
Detailed description
The aim of the present study is to assess the effect of low level laser therapy on treatment outcomes of bony supported distal jet for correction of 20 orthodontic patients with angle class II malocclusion. enrolled patient is randomly divided into 2 groups laser group and distal screw group. for result assessment dental casts and CBCT are taken before and after completion of distalization. both groups receives Distal Jet supported on 2 paramedian screw with laser therapy for laser group only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser group | Experimental | Radiation: low level laser therapy, Device: bonny supported distal jet |
| control group | Active comparator | Device: bonny supported distal jet |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- bilateral Angle's Class II malocclusion minimum of 1/4 cusp discrepancy, normal or low mandibular plane (MP) angle cases and no history of serious medical illness
Key exclusion criteria (1 listed)
- subjects with skeletal Class II with retrusion mandibular profile, vertical growth pattern and steep mandibular plane angle and subjects with shallow or anterior open bite.
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 therapyirradiation with LLLT by the following regimen 0, 3, 7 and 14 from the activation of the bony supported Distal Jet and then every 15 days till completion of distalization | Radiation | Laser group |
| bonny supported distal jetdistal jet distalizing appliance is supported on two paramedian screw | Device | Laser group, control group |
Primary outcome
amount of upper first molar distal movement
Time frame: till achievement of class I molar relation, an average of 1 year
mm/month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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.
Rabab HF elhosseini, MSD principal investigator
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 low level laser therapy and bonny supported distal jet in people with This Study Focus on the Effect of Low-Level Light Therapy on the Amount of Upper Molar Distalization, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabab HF elhosseini, MSD (01143376466 ext. 002, dr.rababelhosseny@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of upper first molar distal movement (time frame: till achievement of class I molar relation, an average of 1 year). 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 14 Dec 2023.