Malocclusion, Angle Class II, Division 1NCT07466641
LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
A study testing Low Level Laser Therapy and Piezocision in people with Malocclusion, Angle Class II, Division 1 and Bimaxillary Protrusion, run by Hesham Nabil Ali Al-Qamhawy at 1 site in Egypt.
Trial summary
This comparative controlled clinical study aims to evaluate and compare the effectiveness of piezocision and low-level laser therapy (LLLT) as adjunctive interventions to accelerate orthodontic canine retraction. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion, Class I Malocclusion
- What is being tested?
- Low Level Laser Therapy and Piezocision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range 18-25 years.
- Patients with crowding or protrusion requiring at least bilateral maxillary first premolar extraction followed by symmetrical canine retraction.
- Full set of permanent dentition (third molar not considered).
- Patients with good oral hygiene.
Who cannot join
- Previous orthodontic treatment.
- Patients taking medications or suffering from systemic conditions that can affect orthodontic tooth movement.
- Active periodontal diseases and/or untreated carious lesions.
- Congenital orofacial deformities.
- Discontinuation criteria:
- Multiple missing appointments.
- Poor oral hygiene.
- Multiple broken appliances to the extent that interferes with obtaining the treatment objectives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient Clinics of the Department of Orthodontics, Faculty of Dental Medicine, Boys, Cairo, Al-Azhar University.
Cairo, Cairo Governorate
About this study
Official title: Effectiveness of Piezocision Versus Low-level Laser Therapy During Orthodontic Canine Retraction: A Comparative Controlled Clinical Study
This comparative controlled clinical study aims to evaluate and compare the effectiveness of piezocision and low-level laser therapy (LLLT) as adjunctive interventions to accelerate orthodontic canine retraction. Participants will be randomly assigned to one of three groups: piezocision, LLLT, or a control group (no adjunctive procedure). The study will assess the impact of these interventions on the rate of tooth movement, the type of tooth movement, and patient experience.
- Being tested
- Low Level Laser Therapy, Piezocision
- Keywords
- canine retraction, Low-level laser therapy, laser, piezocision, piezosurgery, orthodontic canine retraction
- Medical subject headings
- Malocclusion, Angle Class II, Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyProcedure or surgery
Also called LLLT
On both right and left sides, LLLT will be performed at the beginning of canine retraction, after 3, 7, 14 days, and then every 14 days for a total four-month period.
PiezocisionProcedure or surgery
Also called Piezosurgery
On both right and left sides, a minimally invasive flapless piezocision procedure will be performed each month from the beginning of the canine retraction for a total four-month period.
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy group | Experimental | Not described Receives: Procedure: Low Level Laser Therapy |
| Piezocision group | Experimental | Not described Receives: Procedure: Piezocision |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of canine retraction
The rate of distal movement of the maxillary canine measured in millimeters per month (mm/month).
Measured: Four months from the beginning of maxillary canine retraction.
Secondary outcomes (4)
Maxillary canine rotation and tipping.
Measured in degrees
Measured: Four months from the beginning of maxillary canine retraction.
Maxillary first molar mesial movement
Maxillary first molar mesial movement (measured in mm)
Measured: Four months from the beginning of maxillary canine retraction.
Maxillary first molar rotatiob
(measured in degrees).
Measured: Four months from the beginning of maxillary canine retraction.
Patient-Reported Pain Intensity
Pain intensity will be measured using a 10-centimeter Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the worst possible pain" . Therefore, higher scores indicate a worse outcome (greater pain intensity).
Measured: Four months from the beginning of maxillary canine retraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Apr 2026
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class II, Division 1Studies 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hesham Nabil Ali Al-Qamhawy
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor-investigator, Hesham Nabil Ali Al-Qamhawy, Al-Azhar University
- Investigators
- Farouk A Hussein, Professor, Study chair, Professor in Orthodontics; Faculty of Dental Medicine, Boys, Cairo; Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466641
- Sponsor's protocol ID
- 1440/1511
- Status last verified
- May 2026
- First submitted
- 3 Mar 2026
- Last updated
- 11 May 2026
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Piezocision Versus Low-level Laser Therapy During Orthodontic Canine Retraction: A Comparative Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07466641
- Acronym / sponsor ID
- 1440/1511
- Keywords
- canine retraction, Low-level laser therapy, laser, piezocision, piezosurgery, orthodontic canine retraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Hesham Nabil Ali Al-QamhawyUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Mar 2026 (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.
This comparative controlled clinical study aims to evaluate and compare the effectiveness of piezocision and low-level laser therapy (LLLT) as adjunctive interventions to accelerate orthodontic canine retraction. Participants will be randomly assigned to one of three groups: piezocision, LLLT, or a control group (no adjunctive procedure). The study will assess the impact of these interventions on the rate of tooth movement, the type of tooth movement, and patient experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy group | Experimental | Procedure: Low Level Laser Therapy |
| Piezocision group | Experimental | Procedure: Piezocision |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range 18-25 years.
- Patients with crowding or protrusion requiring at least bilateral maxillary first premolar extraction followed by symmetrical canine retraction.
- Full set of permanent dentition (third molar not considered).
- Patients with good oral hygiene.
Key exclusion criteria (8 listed)
- Previous orthodontic treatment.
- Patients taking medications or suffering from systemic conditions that can affect orthodontic tooth movement.
- Active periodontal diseases and/or untreated carious lesions.
- Congenital orofacial deformities.
- Multiple missing appointments.
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: LLLTOn both right and left sides, LLLT will be performed at the beginning of canine retraction, after 3, 7, 14 days, and then every 14 days for a total four-month period. | Procedure or surgery | Low-level laser therapy group |
| PiezocisionAlso: PiezosurgeryOn both right and left sides, a minimally invasive flapless piezocision procedure will be performed each month from the beginning of the canine retraction for a total four-month period. | Procedure or surgery | Piezocision group |
Primary outcome
Rate of canine retraction
Time frame: Four months from the beginning of maxillary canine retraction.
The rate of distal movement of the maxillary canine measured in millimeters per month (mm/month).
4 secondary outcomes
Maxillary canine rotation and tipping.
Time frame: Four months from the beginning of maxillary canine retraction.
Maxillary first molar mesial movement
Time frame: Four months from the beginning of maxillary canine retraction.
Maxillary first molar rotatiob
Time frame: Four months from the beginning of maxillary canine retraction.
Patient-Reported Pain Intensity
Time frame: Four months from the beginning of maxillary canine retraction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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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.
Farouk A Hussein, Professor study chair
Professor in Orthodontics; Faculty of Dental Medicine, Boys, Cairo; 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 Piezocision in people with Malocclusion, Angle Class II, Division 1 and Bimaxillary Protrusion, run by Hesham Nabil Ali Al-Qamhawy 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hesham N Al-Qamhawy (00201099767929, heshamnabil96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of canine retraction (time frame: Four months from the beginning of maxillary canine retraction.). 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 11 May 2026.