NCT07466641

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

March 3, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

March 3, 2026

Last Update Submit

May 6, 2026

Conditions

Bimaxillary ProtrusionMalocclusion, Angle Class II, Division 1Class I Malocclusion

Keywords

canine retractionLow-level laser therapylaserpiezocisionpiezosurgeryorthodontic canine retraction

Outcome Measures

Primary Outcomes (1)

  • Rate of canine retraction

    The rate of distal movement of the maxillary canine measured in millimeters per month (mm/month).

    Four months from the beginning of maxillary canine retraction.

Secondary Outcomes (4)

  • Maxillary canine rotation and tipping.

    Four months from the beginning of maxillary canine retraction.

  • Maxillary first molar mesial movement

    Four months from the beginning of maxillary canine retraction.

  • Maxillary first molar rotatiob

    Four months from the beginning of maxillary canine retraction.

  • Patient-Reported Pain Intensity

    Four months from the beginning of maxillary canine retraction.

Study Arms (3)

Low-level laser therapy group

EXPERIMENTAL
Procedure: Low Level Laser Therapy

Piezocision group

EXPERIMENTAL
Procedure: Piezocision

Control group

NO INTERVENTION

Interventions

Low Level Laser TherapyPROCEDURE

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.

Also known as: LLLT
Low-level laser therapy group
PiezocisionPROCEDURE

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.

Also known as: Piezosurgery
Piezocision group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinics of the Department of Orthodontics, Faculty of Dental Medicine, Boys, Cairo, Al-Azhar University.

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class IIMalocclusion, Angle Class I

Interventions

Low-Level Light TherapyPiezosurgery

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyUltrasonic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Farouk A Hussein, Professor

    Professor in Orthodontics; Faculty of Dental Medicine, Boys, Cairo; Al-Azhar University

    STUDY CHAIR

Central Study Contacts

Hesham N Al-Qamhawy

CONTACT

00201099767929heshamnabil96@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 12, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations

EG(1)