Effect of Low Level Laser Versus Low Intensity Pulsed Ultra Sound on Rate of Different Orthodontic Tooth Movement by MillimeterNCT06026930

Influence of Low-level Laser Therapy Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements

A study testing low-level laser therapy in people with Effect of Low Level Laser Versus Low Intensity Pulsed Ultra Sound on Rate of Different Orthodontic Tooth Movement by Millimeter, run by Al-Azhar University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 15 to 22 yearsHealthy volunteers can take part
Conditions the study is for: Effect of Low Level Laser Versus Low Intensity Pulsed Ultra Sound on Rate of Different Orthodontic Tooth Movement by Millimeter
What is being tested?: low-level laser therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteEgypt
Study dates: Sep 2023to Apr 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 15 to 22 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

A- leveling and alignment Eligibility criteria
1. Age ranges from 14 to 17 years. 2. Bilateral Class II molar relationship. 3. Skeletal Class I or mild Class II relationship. 4. Normal or decreased vertical height. 5. No posterior crowding or spaces. 6. Fully erupted maxillary first and second molars. 7. Congenitally missing or extracted third molars. 8. Good oral hygiene. 9. Absence of any periodontal disease and alveolar bone loss. 10. Absence of medications that may inhibit orthodontic movement
Lower incisor leveling and alignment Inclusion criteria Complete permanent dentition (third molars not included); Moderate mandibular anterior crowding (with little's irregularity index score greater than 4 mm) who required non-extraction approach in the mandibular arch; No tooth size, shape or root abnormalities visible on the patient's radiographic records; No spaces in the mandibular arch; No blocked out tooth that did not allow for placement of the bracket at the
initial bonding appointment; 6. No required management with interproximal stripping, inter-maxillary elastics, open NiTi springs, and removable or extra-oral devices. Canine retraction Eligibility criteria
Age, 15 to 25 years; Class ii division 1 malocclusion with mild or no crowding; No previous orthodontic treatment; No systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, or vitamin d deficiency; Adequate oral hygiene; Probing depth values not exceeding 3 mm across the Entire dentition; Adequate thickness of the attached gingiva (1-2 mm); No radiographic evidence of bone loss

Who cannot join

Patients who required surgery to correct skeletal discrepancies. Patients with congenital dentoskeletal disorders. Missed or mutilated teeth in maxillary arch. Patients with poor oral hygiene and/or periodontally compromised patients Severe dental crowding that necessitates an extraction approach 2. Abnormal anteroposterior and vertical relationships; 3. Patients with cleft lip and palate, anomalies, and syndromes; 4. Previous orthodontic 5. Treatment; 6. Regular medications intake that could interfere with otm. -

Trial locations and contacts

1 site in 1 country.

Egypt1 site

AlAzhar university
Cairo

Other trials in Egypt

About this study

Official title: Influence of Low-level Laser Therapy Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements: A Comparative Clinical Investigation

The aim of this prospective clinical project will be to compare the effect of low-level laser therapy versus low intensity pulsed ultrasound on the rate of different orthodontic tooth movements

Read the detailed description

The aim of this prospective clinical project will be to compare the effect of low-level laser therapy versus low intensity pulsed ultrasound on the rate of different orthodontic tooth movements, specifically; canine retraction, incisors' leveling and alignment, maxillary molar distalization, and incisors' intrusion

Conditions: Effect of Low Level Laser Versus Low Intensity Pulsed Ultra Sound on Rate of Different Orthodontic Tooth Movement by Millimeter
Being tested: low-level laser therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

low-level laser therapyDevice
Also called low intensity pulsed ultrasound
LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.

Study groups in NCT06026930
Study group	Role	What they receive
Lipus side: canine retraction	Experimental	application of LIPUS with translation of maxillary canine that will be performed on intervention sides according to a standardized protocol Receives: Device: low-level laser therapy
LIPUS side control side	No intervention	LIPUS side:canine retraction control side
LLLT side canine retraction	Experimental	translation of maxillary canine that will be performed with LLLT application according to a standardized protocol Receives: Device: low-level laser therapy
LLLT side canine retraction control side	No intervention	LLLT side canine retraction control side wihout intervention
LIPUS groupMolar distalization group inrervention side	Experimental	distalization assisted with LIPUS according to a standardized protocol Receives: Device: low-level laser therapy
LIPUS groupMolar distalization group control side	No intervention	distalization without LIPUS intervention
LLLT group: distalization intervntion side	Experimental	distalization will be commenced with application of LLLT according to a standardized protocol Receives: Device: low-level laser therapy
LLLT group: distalization control side	No intervention	distalization will be commenced without application of LLLT according to a standardized protocol
LIPUS group: leveling and alignment	Experimental	leveling and alignment assisted with LIPUS according to a standardized protocol Receives: Device: low-level laser therapy
LLLT group: leveling and alignment	Experimental	leveling and alignment be commenced with application of LLLT according to a standardized protocol Receives: Device: low-level laser therapy
leveling and alignment without intervention	No intervention	leveling and alignment without intervention
LIPUS group: Intrusion	Experimental	intrusion assisted with LIPUS according to a standardized protocol Receives: Device: low-level laser therapy
LLLT group: Intrusion	Experimental	intrusion assisted with application of LLLT according to a standardized protocol Receives: Device: low-level laser therapy
intrusion control group	No intervention	intrusion without intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter
rate of orthodontic tooth movement by millimeter
Measured: post interventionalal at 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2023Apr 2024

First posted7 Sep 2023
Study startSep 2023 (estimated)
Primary completionMar 2024 (estimated)
Study completionApr 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Effect of Low Level Laser Versus Low Intensity Pulsed Ultra Sound on Rate of Different Orthodontic Tooth Movement by MillimeterStudies of the same condition, open and under way.
More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
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: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 82 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06026930
Sponsor's protocol ID: 926/91
Status last verified: Sep 2023
First submitted: 19 Aug 2023
Last updated: 7 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Maurya RK, Singh H, Kapoor P, Jain U, Mitra R. Effects of low-level laser and low-intensity pulsed ultrasound therapy on treatment duration and pain perception. J Clin Orthod. 2019 Mar;53(3):154-162. No abstract available.
PubMed 31009384
El-Bialy T, Farouk K, Carlyle TD, Wiltshire W, Drummond R, Dumore T, Knowlton K, Tompson B. Effect of Low Intensity Pulsed Ultrasound (LIPUS) on Tooth Movement and Root Resorption: A Prospective Multi-Center Randomized Controlled Trial. J Clin Med. 2020 Mar 16;9(3):804. doi: 10.3390/jcm9030804.
PubMed 32188053
Qamruddin I, Alam MK, Mahroof V, Karim M, Fida M, Khamis MF, Husein A. Biostimulatory Effects of Low-Intensity Pulsed Ultrasound on Rate of Orthodontic Tooth Movement and Associated Pain, Applied at 3-Week Intervals: A Split-Mouth Study. Pain Res Manag. 2021 May 5;2021:6624723. doi: 10.1155/2021/6624723. eCollection 2021.
PubMed 34035871

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Low-level Laser Therapy Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements: A Comparative Clinical Investigation
ClinicalTrials.gov ID: NCT06026930
Acronym / sponsor ID: 926/91
Conditions: Effect of Low Level Laser Versus Low Intensity Pulsed Ultra Sound on Rate of Different Orthodontic Tooth Movement by Millimeter
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 82 participants (estimated)
Lead sponsor: Al-Azhar UniversityUniversity, hospital or other
Study start: Sep 2023 (estimated)
Primary completion: Mar 2024 (estimated)
Study completion: Apr 2024 (estimated)
First posted: 7 Sep 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 aim of this prospective clinical project will be to compare the effect of low-level laser therapy versus low intensity pulsed ultrasound on the rate of different orthodontic tooth movements

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 14

Arm	Type	Receives
Lipus side: canine retraction	Experimental	Device: low-level laser therapyapplication of LIPUS with translation of maxillary canine that will be performed on intervention sides according to a standardized protocol
LIPUS side control side	No intervention	–LIPUS side:canine retraction control side
LLLT side canine retraction	Experimental	Device: low-level laser therapytranslation of maxillary canine that will be performed with LLLT application according to a standardized protocol
LLLT side canine retraction control side	No intervention	–LLLT side canine retraction control side wihout intervention
LIPUS groupMolar distalization group inrervention side	Experimental	Device: low-level laser therapydistalization assisted with LIPUS according to a standardized protocol
LIPUS groupMolar distalization group control side	No intervention	–distalization without LIPUS intervention
LLLT group: distalization intervntion side	Experimental	Device: low-level laser therapydistalization will be commenced with application of LLLT according to a standardized protocol
LLLT group: distalization control side	No intervention	–distalization will be commenced without application of LLLT according to a standardized protocol
LIPUS group: leveling and alignment	Experimental	Device: low-level laser therapyleveling and alignment assisted with LIPUS according to a standardized protocol
LLLT group: leveling and alignment	Experimental	Device: low-level laser therapyleveling and alignment be commenced with application of LLLT according to a standardized protocol
leveling and alignment without intervention	No intervention	–leveling and alignment without intervention
LIPUS group: Intrusion	Experimental	Device: low-level laser therapyintrusion assisted with LIPUS according to a standardized protocol
LLLT group: Intrusion	Experimental	Device: low-level laser therapyintrusion assisted with application of LLLT according to a standardized protocol
intrusion control group	No intervention	–intrusion without intervention

Who may qualify

Ages: 15 to 22 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

A- leveling and alignment Eligibility criteria
1. Age ranges from 14 to 17 years. 2. Bilateral Class II molar relationship. 3. Skeletal Class I or mild Class II relationship. 4. Normal or decreased vertical height. 5. No posterior crowding or spaces. 6. Fully erupted maxillary first and second molars. 7. Congenitally missing or extracted third molars. 8. Good oral hygiene. 9. Absence of any periodontal disease and alveolar bone loss. 10. Absence of medications that may inhibit orthodontic movement
Lower incisor leveling and alignment Inclusion criteria Complete permanent dentition (third molars not included); Moderate mandibular anterior crowding (with little's irregularity index score greater than 4 mm) who required non-extraction approach in the mandibular arch; No tooth size, shape or root abnormalities visible on the patient's radiographic records; No spaces in the mandibular arch; No blocked out tooth that did not allow for placement of the bracket at the
initial bonding appointment; 6. No required management with interproximal stripping, inter-maxillary elastics, open NiTi springs, and removable or extra-oral devices. Canine retraction Eligibility criteria
Age, 15 to 25 years; Class ii division 1 malocclusion with mild or no crowding; No previous orthodontic treatment; No systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, or vitamin d deficiency; Adequate oral hygiene; Probing depth values not exceeding 3 mm across the Entire dentition; Adequate thickness of the attached gingiva (1-2 mm); No radiographic evidence of bone loss

Key exclusion criteria (1 listed)

Patients who required surgery to correct skeletal discrepancies. Patients with congenital dentoskeletal disorders. Missed or mutilated teeth in maxillary arch. Patients with poor oral hygiene and/or periodontally compromised patients Severe dental crowding that necessitates an extraction approach 2. Abnormal anteroposterior and vertical relationships; 3. Patients with cleft lip and palate, anomalies, and syndromes; 4. Previous orthodontic 5. Treatment; 6. Regular medications intake that could interfere with otm. -

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 therapyAlso: low intensity pulsed ultrasoundLLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.	Device	LIPUS group: Intrusion, LIPUS group: leveling and alignment, LIPUS groupMolar distalization group inrervention side, LLLT group: Intrusion, LLLT group: distalization intervntion side, LLLT group: leveling and alignment, LLLT side canine retraction, Lipus side: canine retraction

Primary outcome

Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter
Time frame: post interventionalal at 6months
rate of orthodontic tooth movement by millimeter

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
Results publication: PubMed 31009384Maurya RK, Singh H, Kapoor P, Jain U, Mitra R. Effects of low-level laser and low-intensity pulsed ultrasound therapy on treatment duration and pain perception. J Clin Orthod. 2019 Mar;53(3):154-162. No abstract available.
Results publication: PubMed 32188053El-Bialy T, Farouk K, Carlyle TD, Wiltshire W, Drummond R, Dumore T, Knowlton K, Tompson B. Effect of Low Intensity Pulsed Ultrasound (LIPUS) on Tooth Movement and Root Resorption: A Prospective Multi-Center Randomized Controlled Trial. J Clin Med. 2020 Mar 16;9(3):804. doi: 10.3390/jcm9030804.
Results publication: PubMed 34035871Qamruddin I, Alam MK, Mahroof V, Karim M, Fida M, Khamis MF, Husein A. Biostimulatory Effects of Low-Intensity Pulsed Ultrasound on Rate of Orthodontic Tooth Movement and Associated Pain, Applied at 3-Week Intervals: A Split-Mouth Study. Pain Res Manag. 2021 May 5;2021:6624723. doi: 10.1155/2021/6624723. eCollection 2021.
Individual participant dataSharing planned: Yes

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 7 Sep 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?

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?

Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter (time frame: post interventionalal at 6months). 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 NCT06026930, which also lists 3 linked publications.

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 7 Sep 2023.